Chapter IV Chapter IV

17.1 For raw materials and packaging materials. - They shall include-(a) the designated name and internal code reference; (b) reference, if any, to a pharmacopoeial monograph; (c) qualitative and quantitative requirements with acceptance limits; (d) name and address of manufacturer or supplier and original manufacturer of the material; (e) specimen of printed material; (f) directions for sampling and testing or reference to procedures; (g) storage conditions; and (h) maximum period of storage before re-testing. 17.2 For product containers and closures:– 17.2.1 All containers and closures intended for use shall comply with the pharmacopoeial requirements. Suitable validt. test methods, sample sizes, specifications, cleaning procedure and sterilization procedure, wherever indicated, shall be strictly followed to ensure that these are not reactive, additive, absorptive, or leach to an extent that significantly affects the quality or purity of the drug. No second hand or used containers and closures shall be used. 17.2.2 Whenever bottles are being used, the written schedule of cleaning shall be laid down and followed. Where bottles are not dried after washing, they should be rinsed with de-ionised water or distilled water, as the case may be.

17A. Adulterated drugs.—For the purposes of this Chapter, a drug shall be deemed to be adulterated,— (a) if it consists in whole or in part, of any filthy, putrid or decomposed substance; or (b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or (c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (d) if it bears or contains, for the purposes of colouring only, a colour other than one which is prescribed; or (e) if it contains any harmful or toxic substance which may render it injurious to health; or (f) if any substance has been mixed therewith so as to reduce its quality or strength.

17B. Spurious drugs.—For the purposes of this Chapter, a drug shall be deemed to be spurious,— (a) if it is manufactured under a name which belongs to another drug; or (b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug ; or (c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug , which individual or company is fictitious or does not exist; or (d) if it has been substituted wholly or in part by another drug or substance; or (e) if it purports to be the product of a manufacturer of whom it is not truly a product.

17C. Misbranded cosmetics.—For the purposes of this Chapter, a cosmetic shall be deemed to be misbranded, -- (a) if it contains a colour which is not prescribed; or (b) if it is not labelled in the prescribed manner; or (c) if the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular.

17D. Spurious cosmetics.—For the purposes of this Chapter, a cosmetic shall be deemed to be spurious,-- (a) if it is manufactured under a name which belongs to another cosmetic; or (b) if it is an imitation of, or is a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon it or upon its label or container the name of another cosmetic unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other cosmetic; or

From such date as may be fixed by the State Government by notification in the Official Gazette in this behalf, no person shall himself or by any other person on his behalf—

(a) manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale or distribute—

(i) any drug which is not of a standard quality, or is misbranded, adulterated or spurious;

(ii) any cosmetic which is not of a standard quality or is misbranded or spurious;

(iii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof the true formula or list of active ingredients contained in it together with the quantities thereof;

(iv) any drug which by means of any statement, design or device accompanying it or by any other means, purports or claims to prevent, cure or mitigate any such disease or ailment, or to have any such other effect as may be prescribed;

(v) any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended;

(vi) any drug or cosmetic in contravention of any of the provisions of this Chapter or any rule made thereunder;

(b) sell, or stock or exhibit or offer for sale, or distribute any drug or cosmetic which has been imported or manufactured in contravention of any of the provisions of this Act or any rule made thereunder;

(c) manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale, or distribute any drug or cosmetic, except under, and in accordance with the conditions of, a licence issued for such purpose under this Chapter :

Provided that nothing in this section shall apply to the manufacture, subject to prescribed conditions, of small quantities of any drug for the purpose of examination, test or analysis:

Provided further that the Central Government may, after consultation with the Board, by notification in the Official Gazette, permit, subject to any conditions specified in the notification, the manufacture for sale, or for distribution, sale, stocking or exhibiting or offering for sale or distribution of any drug or class of drugs not being of standard quality.

Every person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall, if so required, disclose to the Inspector the name, address and other particulars of the person from whom he acquired the drug or cosmetic.

Every person holding a licence under clause (c) of section 18 shall keep and maintain such records, registers and other documents as may be prescribed and shall furnish to any officer or authority exercising any power or discharging any function under this Act such information as is required by such officer or authority for carrying out the purposes of this Act.

(1) Save as hereinafter provided in this section, it shall be no defence in a prosecution under this Chapter to prove merely that the accused was ignorant of the nature, substance or quality of the drug or cosmetic in respect of which the offence has been committed or of the circumstances of its manufacture or import, or that a purchaser, having bought only for the purpose of test or analysis, has not been prejudiced by the sale.

(2) For the purposes of section 18 a drug shall not be deemed to be misbranded or adulterated or spurious or to be below standard quality nor shall a cosmetic be deemed to be misbranded or to be below standard quality only by reason of the fact that—

(a) there has been added thereto some innocuous substance or ingredient because the same is required for manufacture or preparation of the drug or cosmetic as an article of commerce in a state fit for carriage or consumption, and not to increase the bulk, weight or measure of the drug or cosmetic or to conceal its inferior quality or other defects; or

(b) in the process of manufacture, preparation or conveyance some extraneous substance has unavoidably become intermixed with it: Provided that this clause shall not apply in relation to any sale or distribution of the drug or cosmetic occurring after the vendor or distributor became aware of such intermixture.

(3) A person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall not be liable for a contravention of section 18 if he proves—

(a) that he acquired the drug or cosmetic from a duly licensed manufacturer, distributor or dealer thereof;

(b) that he did not know and could not, with reasonable diligence, have ascertained that the drug or cosmetic in any way contravened the provisions of that section; and

(c) that the drug or cosmetic, while in his possession, was properly stored and remained in the same state as when he acquired it.

(1) The State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts for such areas in the state and in respect of such drugs or classes of drugs or such cosmetics or classes of cosmetics as may be specified in the notification.

(2) The Central Government may also, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts in respect of such drugs or classes of drugs or such cosmetics or classes of cosmetics as may be specified in the notification.

(3) Notwithstanding anything contained in sub-section (1) or sub-section (2), neither the Central Government nor a State Government shall appoint as a Government Analyst any official not serving under it without the previous consent of the Government under which he is serving.

(4) No person who has any financial interest in the import, manufacture or sale of drugs or cosmetics shall be appointed to be a Government Analyst under sub-section (1) or sub-section (2) of this section.

21.1 There shall be Batch Processing Record for each product. It shall be based on the relevant parts of the currently approved Master Formula. The method of preparation of such records included in the Master Formula shall be designed to avoid transcription errors. 21.2 Before any processing begins, check shall be performed and recorded to ensure that the equipment and work station are clear of previous products, documents or materials not required for the planned process are removed and the equipment is clean and suitable for use. 21.3 During processing, the following information shall be recorded at the time each action is taken and the record shall be dt. and signed by the person responsible for the processing operations: - (a) the name of the product, (b) the number of the batch being manufactured, (c) dates and time of commencement, of significant intermediate stages and of completion of production, (d) initials of the operator of different significant steps of production and where appropriate, of the person who checked each of these operations, (e) the batch number and/or analytical control number as well as the quantities of each starting material actually weighed, (f) any relevant processing operation or event and major equipment used, (g) a record of the in-process controls and the initials of the person(s) carrying them out, and the results obtained, (h) the amount of product obtained after different and critical stages of manufacture (yield), (i) comments or explanations for significant deviations from the expected yield limits shall be given, (j) notes on special problems including details, with signed authorization, for any deviation from the Master Formula, (k) addition of any recovered or reprocessed material with reference to recovery or reprocessing stages.

(1) Subject to the provisions of section 23 and of any rules made by the Central Government in this behalf, an Inspector may, within the local limits of the area for which he is appointed,— (a) inspect,— (i) any premises wherein any drug or cosmetic is being manufactured and the means employed for standardising and testing the drug or cosmetic; (ii) any premises wherein any drug or cosmetic is being sold, or stocked or exhibited or offered for sale, or distributed; (b) take samples of any drug or cosmetic,— (i) which is being manufactured or being sold or is stocked or exhibited or offered for sale, or is being distributed; (ii) from any person who is in the course of conveying, delivering or preparing to deliver such drug or cosmetic to a purchaser or a consignee; (c) at all reasonable times, with such assistance, if any, as he considers necessary,-- (i) search any person, who, he has reason to believe, has secreted about his person, any drug or cosmetic in respect of which an offence under this Chapter has been, or is being, committed; or (ii) enter and search any place in which he has reason to believe that an offence under this Chapter has been, or is being, committed; or (iii) stop and search any vehicle, vessel or other conveyance which, he has reason to believe, is being used for carrying any drug or cosmetic in respect of which an offence under this Chapter has been, or is being, committed, and order in writing the person in possession of the drug or cosmetic in respect of which the offence has been, or is being, committed, not to dispose of any stock of such drug or cosmetic for a specified period not exceeding twenty days, or, unless the alleged offence is such that the defect may be removed by the possessor of the drug or cosmetic, seize the stock of such drug or cosmetic and any substance or article by means of which the offence has been, or is being, committed or which may be employed for the commission of such offence; (cc) examine any record, register, document or any other material object found with any person, or in any place, vehicle, vessel or other conveyance referred to in clause (c), and seize the same if he has reason to believe that it may furnish evidence of the commission of an offence punishable under this Act or the rules made thereunder; (cca) require any person to produce any record, register, or other document relating to the manufacture for sale or for distribution, stocking, exhibition for sale, offer for sale or distribution of any drug or cosmetic in respect of which he has reason to believe that an offence under this Chapter has been, or is being, committed; (d) exercise such other powers as may be necessary for carrying out the purposes of this Chapter or any rules made thereunder. (2) The provisions of the Code of Criminal Procedure, 1973 (2 of 1974) shall, so far as may be, apply to any search or seizure under this Chapter as they apply to any search or seizure made under the authority of a warrant issued under section 94 of the said Code. (2A) Every record, register or other document seized under clause (cc) or produced under clause (cca) shall be returned to the person, from whom they were seized or who produce the same, within a period of twenty days of the date of such seizure or production, as the case may be, after copies thereof or extracts therefrom certified by that person, in such manner as may be prescribed, have been taken. (3) If any person wilfully obstructs an Inspector in the exercise of the powers conferred upon him by or under this Chapter, or refuses to produce any record, register or other document when so required under clause (cca) of sub-section (1), he shall be punishable with imprisonment which may extend to three years, or with fine, or with both.

(1) Where an Inspector takes any sample of a drug or cosmetic under this Chapter, he shall tender the fair price thereof and may require a written acknowledgment therefor. (2) Where the price tendered under sub-section (1) is refused, or where the Inspector seizes the stock of any drug or cosmetic under clause (c) of section 22, he shall tender a receipt therefor in the prescribed form. (3) Where an Inspector takes a sample of a drug or cosmetic for the purpose of test or analysis, he shall intimate such purpose in writing in the prescribed form to the person from whom he takes it and, in the presence of such person unless he wilfully absents himself, shall divide the sample into four portions and effectively seal and suitably mark the same and permit such person to add his own seal and mark to all or any of the portions so sealed and marked: Provided that where the sample is taken from premises whereon the drug or cosmetic is being manufactured, it shall be necessary to divide the sample into three portions only: Provided further that where the drug or cosmetic is made up in containers of small volume, instead of dividing a sample as aforesaid, the Inspector may, and if the drug or cosmetic be such that it is likely to deteriorate or be otherwise damaged by exposure shall, take three or four, as the case may be, of the said containers after suitably marking the same and, where necessary, sealing them. (4) The Inspector shall restore one portion of a sample so divided or one container, as the case may be, to the person from whom he takes it, and shall retain the remainder and dispose of the same as follows:— (i) one portion or container he shall forthwith send to the Government Analyst for test or analysis; (ii) the second he shall produce to the Court before which proceedings, if any, are instituted in respect of the drug or cosmetic; (iii) the third, where taken, he shall send to the person, if any, whose name, address and other particulars have been disclosed under section 18A. (5) Where an Inspector takes any action under clause (c) of section 22,— (a) he shall use all despatch in ascertaining whether or not the drug or cosmetic contravenes any of the provisions of the section 18 and, if it is ascertained that the drug or cosmetic does not so contravene, forthwith revoke the order passed under the said clause or, as the case may be, take such action as may be necessary for the return of the stock seized; (b) if he seizes the stock of the drug or cosmetic, he shall as soon as may be inform a Judicial Magistrate and take his orders as to the custody thereof; (c) without prejudice to the institution of any prosecution, if the alleged contravention be such that the defect may be remedied by the possessor of the drug or cosmetic, he shall, on being satisfied that the defect has been so remedied, forthwith revoke his order under the said clause.

(1) An application for an import licence shall be made to the licensing authority in Form 8 for drugs excluding those specified in Schedule X, and in Form 8-A for drugs specified in Schedule X, either by the manufacturer himself having a valid wholesale licence for sale or distribution of drugs under these Rules, or by the manufacturer’s agent in India either having a valid licence under the Rules to manufacture for sale of a drug or having a valid wholesale licence for sale or distribution of drugs under these Rules, and shall be accompanied by a licence fee of Rs. 1,000 for a single drug and an additional fee at the rate of Rs. 100 for each additional drug and by an undertaking in Form 9 duly signed by or on behalf of the manufacturer:

Provided that in the case of any subsequent application made by the same importer for import licence for drugs manufactured by the same manufacturer, the fee to accompany each such application shall be Rs. 100 for each drug:

(2) Any application for import licence in Form 8 or Form 8-A, as the case may be, shall be accompanied by a copy of Registration Certificate issued in Form 41 under Rule 27-A:

Provided that in case of emergencies the licensing authority may, with the approval of the Central Government, issue an import licence in Form 10 or 10-A, as the case may be, without the issuance of Registration Certificate under Rule 27-A, for reasons to be recorded in writing.

Provided further that Registration certificate shall not be required to be accompanied with an application for an import licence under the Rules for the import of in-vitro diagnostic kits and regents, except for the diagnostic kits notified from time to time under sub-clause (iv) of clause (b) of section 3.

(3) A fee of Rs. 250 shall be paid for a duplicate copy of the licence issued under this Rule, if the original is defaced, damaged or lost.

(1) The Government Analyst to whom a sample of any drug or cosmetic has been submitted for test or analysis under sub-section (4) of section 23, shall deliver to the Inspector submitting it a signed report in triplicate in the prescribed form.

(2) The Inspector on receipt thereof shall deliver one copy of the report to the person from whom the sample was taken and another copy to the person, if any, whose name, address and other particulars have been disclosed under section 18A, and shall retain the third copy for use in any prosecution in respect of the sample.

(3) Any document purporting to be a report signed by a Government Analyst under this Chapter shall be evidence to the facts stated therein, and such evidence shall be conclusive unless the person from whom the sample was taken or the person whose name, address and other particulars have been disclosed under section 18A has, within twenty-eight days of the receipt of a copy of the report, notified in writing the Inspector or the Court before which any proceedings in respect of the sample are pending that he intends to adduce evidence in controversion of the report.

(4) Unless the sample has already been tested or analysed in the Central Drugs Laboratory, where a person has under sub-section (3) notified his intention of adducing evidence in controversion of a Government Analyst’s report, the Court may, of its own motion or in its discretion at the request either of the complainant or the accused, cause the sample of the drug or cosmetic produced before the Magistrate under sub-section (4) of section 23 to be sent for test or analysis to the said Laboratory, which shall make the test or analysis and report in writing signed by, or under the authority of, the Director of the Central Drugs Laboratory the result thereof, and such report shall be conclusive evidence of the facts stated therein.

(5) The cost of a test or analysis made by the Central Drugs Laboratory under sub-section (4) shall be paid by the complainant or accused as the Court shall direct.

An import licence shall be subject to the following conditions: (i) the manufacturer shall at all times observe the undertaking given by him or on his behalf in Form 9; (ii) the licensee shall allow any Inspector authorised by the licensing authority in that behalf to enter with or without notice any premises where the imported substance is stocked, to inspect the means, if any, employed for testing the substance and to take samples; (iii) the licensee shall on request furnish to the licensing authority from every batch of each substance or from such batch or batches as the licensing authority may from time to time specify a sample of such amount as the licensing authority may consider adequate for any examination required to be made, and the licensee shall, if so required, furnish full protocols of the tests, if any, which have been applied; (iv) if the licensing authority so directs the licensee shall not sell or offer for sale any batch in respect of which a sample is or protocols are furnished under the last preceding sub-rule until a certificate authorising the sale of the batch has been issued to him by or on behalf of the licensing authority; (v) the licensee shall, on being informed by the licensing authority that any part of any batch of the substance has been found by the licensing authority not to conform with the standards of strength, quality and purity prescribed by Chapter III of the Act, or the rules thereunder and on being directed so to do, withdraw the remainder of that batch from sale and, so far as may in the particular circumstances of the case be practicable, recall the issues already made from that batch; (vi) the licensee shall maintain a record of all sales by him of substances for the import of which a licence is required, showing particulars of the substance and of the person to whom sold and such further particulars, if any, as the licensing authority may specify and such record shall be open to the inspection of any Inspector authorised in that behalf by the licensing authority: Provided that in respect of the sale or distribution of drugs specified in Schedule X, the licensee shall maintain a separate record or register showing the following particulars, namely: 1. Name of the Drug, 2. Batch number, 3. Name and address of the manufacturer, 4. Date of transaction, 5. Opening stock on the business day, 6. Quantity of drug received, if any, and the source from which received, 7. Name of the purchaser, his address and licence number, 8. Balance quantity of drug at the end of the business day, 9. Signature of the person under whose supervision the drugs have been supplied. (vii) the licensee shall comply with such further requirements, if any, applicable to the holders of import licenses, as may be specified in any Rules, subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than four months’ notice.

Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied, that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do, then, that Government may, by notification in the Official Gazette, prohibit the manufacture, sale or distribution of such drug or cosmetic.

Whoever, himself or by any other person on his behalf, manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale or distributes, —

(a) any drug deemed to be adulterated under section 17A or spurious under section 17B or which when used by any person for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder is likely to cause his death or is likely to cause such harm on his body as would amount to grievous hurt within the meaning of section 320 of the Indian Penal Code (45 of 1860), solely on account of such drug being adulterated or spurious or not of standard quality, as the case may be, shall be punishable with imprisonment for a term which shall not be less than five years but which may extend to a term of life and with fine which shall not be less than Rs. 10,000;

(b) any drug—

(i) deemed to be adulterated under section 17A, but not being a drug referred to in clause (a), or

(ii) without a valid licence as required under clause (c) of section 18,

shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to three years and with fine which shall not be less than Rs. 5,000:

Provided that the Court may, for any adequate and special reasons to be recorded in the judgment, impose a sentence of imprisonment for a term of less than one year and of fine of less than Rs. 5,000;

(c) any drug deemed to be spurious under section 17B, but not being a drug referred to in clause (a) shall be punishable with imprisonment for a term which shall not be less than three years but which may extend to five years and with fine which shall not be less than Rs. 5,000:

Provided that the Court may, for any adequate and special reasons, to be recorded in the judgment, impose a sentence of imprisonment for a term of less than three years but not less than one year;

(d) any drug, other than a drug referred to in clause (a) or clause (b) or clause (c), in contravention of any other provision of this Chapter or any rule made thereunder, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to two years and with fine:

Provided that the Court may, for any adequate and special reasons, to be recorded in the judgment impose a sentence of imprisonment for a term of less than one year.

Whoever himself or by any other person on his behalf manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale—

(i) any cosmetic deemed to be spurious under section 17C shall be punishable with imprisonment for a term which may extend to three years and with fine;

(ii) any cosmetic other than a cosmetic referred to in clause (i) above in contravention of any provision of this Chapter or any rule made thereunder shall be punishable with imprisonment for a term which may extend to one year or with fine which may extend to Rs. 1,000 or with both.

28.1 All complaints thereof concerning product quality shall be carefully reviewed and recorded according to written procedures. Each complaint shall be investigated/evaluated by the designated personnel of the company and records of investigation and remedial action taken thereof shall be maintained. 28.2. Reports of serious adverse drug reactions resulting from the use of a drug along with comments and documents shall be forthwith reported to the concerned licensing authority. 28.3 There shall be written procedures describing the action to be taken, recall to be made of the defective product.

Whoever without reasonable cause or excuse, contravenes the provisions of section 18B shall be punishable with imprisonment for a term which may extend to one year or with fine which may extend to Rs. 1,000 or with both.

Whoever himself or by any other person on his behalf manufactures or sells or distributes any drug or cosmetic in contravention of the provisions of any notification issued under section 26A, shall be punishable with imprisonment for a term which may extend to three years and shall also be liable to fine which may extend to Rs. 5,000.

29. Site Master File. –The licensee shall prepare a succinct document in the form of ‘Site Master File’ containing specific and factual Good Manufacturing Practices about the production and/or control of pharmaceutical manufacturing preparations carried out at the licensed premises. It shall contain the following: - 29.1 General information: (a) brief information of the firm; (b) pharmaceutical manufacturing activities as permitted by the licensing authority; (c) other manufacturing activities, if any, carried out on the premises; (d) type of products licensed for manufacture with flow charts mentioning procedure and process flow; (e) number of employees engaged in the production, quality control, storage and distribution; (f) use of outside scientific, analytical or other technical assistance in relation to manufacture and analysis; (g) short description of the Quality Management System of the firm; and (h) products details registered with foreign countries. 29.2 Personnel: (a) organisational chart showing the arrangement for quality assurance including production and quality control; (b) qualification, experience and responsibilities of key personnel; (c) outline for arrangements for basic and in-service training and how the records are maintained; (d) health requirements for personnel engaged in production; and (e) personnel hygiene requirements, including clothing. 29.3 Premises: (a) simple plan or description of manufacturing areas drawn to scale; (b) nature of construction and fixtures/fittings; (c) brief description of ventilation systems. More details should be given for critical areas with potential risk of airborne contamination (schematic drawing of systems). Classification of the rooms used for the manufacture of sterile products should be mentioned; (d) special areas for the handling of the highly toxic, hazardous and sensitizing materials; (e) brief description of water system (schematic drawings of systems), including sanitation; (f) description of planned preventive maintenance programs for premises and of the recording system. 29.4 Equipment: (a) brief description of major equipment used in production and Quality Control Laboratories (a list of equipment required); (b) description of planned preventive maintenance programs for equipment and of the recording system; and (c) qualification and calibration including the recording systems and arrangements for computerized systems validation. 29.5 Sanitation: (a) availability of written specifications and procedures for cleaning manufacturing areas and equipment. 29.6 Documentation. - (a) arrangements for the preparation, revision and distribution of; (b) necessary documentation for the manufacture; (c) any other documentation related to product quality that is not mentioned elsewhere (e.g. microbiological controls about air and water). 29.7 Production:. (a) brief description of production operations using, wherever possible, flow sheets and charts specifying important parameters; (b) arrangements for the handling of starting materials, packaging materials, bulk and

(a) under clause (b) of section 27 is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which shall not be less than two years but which may extend to six years and with fine which shall not be less than Rs. 10,000:

Provided that the Court may, for any adequate and special reasons to be mentioned in the judgment, impose a sentence of imprisonment for a term of less than two years and of fine of less than Rs. 10,000;

(b) under clause (c) of section 27, is again convicted of an offence under that clause shall be punishable with imprisonment for a term which shall not be less than six years but which may extend to ten years and with fine which shall not be less than Rs. 10,000;

(c) under clause (d) of section 27, is again convicted of an offence under that clause shall be punishable with imprisonment for a term which shall not be less than two years but which may extend to four years or with fine which shall not be less than Rs. 5,000, or with both.

(1) Where any person has been convicted under this Chapter for contravening any such provision of this Chapter or any rule made thereunder as may be specified by rule made in this behalf, the stock of the drug or cosmetic in respect of which the contravention has been made shall be liable to confiscation and if such contravention is in respect of—

(i) manufacture of any drug deemed to be misbranded under section 17, adulterated under section 17A or spurious under section 17B; or

(ii) manufacture for sale, or for distribution, sale, or stocking or exhibiting or offering for sale, or distribution of any drug without a valid licence as required under clause (c) of section 18;

any implements or machinery used in such manufacture, sale or distribution and any receptacles, packages or coverings in which such drug is contained and the animals, vehicles, vessels or other conveyances used in carrying such drug shall also be liable to confiscation.

(2) Without prejudice to the provisions contained in sub-section (1) where the Court is satisfied, on the application of an Inspector or otherwise and after such inquiry as may be necessary that the drug or cosmetic is not of standard quality misbranded, adulterated or spurious drug or misbranded or spurious cosmetic, such drug or, as the case may be, such cosmetic shall be liable to confiscation.

The provisions of this Chapter except those contained in section 31 shall apply in relation to the manufacture, sale or distribution of drugs of any department of Government as they apply in relation to the manufacture, sale or distribution of drugs by any other person.

(1) No prosecution under this Chapter shall be instituted except by an Inspector or by the person aggrieved or by a recognised consumer association whether such person is a member of that association or not.

(2) No court inferior to that of a Metropolitan Magistrate or of a Judicial Magistrate of the first class shall try an offence punishable under this Chapter.

(3) Nothing contained in this Chapter shall be deemed to prevent any person from being prosecuted under any other law for any act or omission which constitutes an offence against this Chapter.

Where, at any time during the trial of any offence under this Chapter alleged to have been committed by any person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, the Court is satisfied, on the evidence adduced before it, that such manufacturer or agent is also concerned in that offence, then, the Court may, notwithstanding anything contained in sub-sections (1), (2) and (3) of section 319 of the Code of Criminal Procedure,1973 (2 of 1974) proceed against him as though a prosecution had been instituted against him under section 32.

(1) The Central Government may after consultation with, or on the recommendation of, the Board and after previous publication by notification in the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter:

Provided that consultation with the Board may be dispensed with if the Central Government is of opinion that circumstances have arisen which render it necessary to make rules without such consultation, but in such a case the Board shall be consulted within six months of the making of the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules.

(2) Without prejudice to the generality of the foregoing power, such rules may—

(a) provide for the establishment of laboratories for testing and analysing drugs or cosmetics;

(b) prescribed the qualifications and duties of Government Analysts and the qualifications of Inspectors;

(c) prescribe the methods of test or analysis to be employed in determining whether a drug or cosmetic is of standard quality;

(d) prescribe, in respect of biological and organometallic compounds, the units or methods of standardisation;

(dd) prescribe under clause (d) of section 17A the colour or colours which a drug may bear or contain for purposes of colouring;

(e) prescribe the forms of licences for the manufacture for sale or for distribution, for the sale and for the distribution of drugs or any specified drug or class of drugs or of cosmetics or any specified cosmetic or class of cosmetics, the form of application for such licences, the conditions subject to which such licences may be issued, the authority empowered to issue the same, the qualification of such authority and the fees payable therefor and provide for the cancellation or suspension of such licences in any case where any provision of this Chapter or the rules made thereunder is contravened or any of the conditions subject to which they are issued is not complied with;

(ee) prescribe the records, registers or other documents to be kept and maintained under section 18B;

(eea) prescribe the fees for the inspection (for the purposes of grant or renewal of licence) of premises, wherein any drug or cosmetic is being or is proposed to be manufactured;

(eeb) prescribe the manner in which copies are to be certified under sub-section (2A) of section 22;

(f) specify the diseases or ailments which a drug may not purport or claim to prevent, cure or mitigate and such other effects which a drug may not purport or claim to have;

(g) prescribe the conditions subject to which small quantities of drugs may be manufactured for the purpose of examination, test or analysis.

Small quantities of new drug, as defined in Rule 122-E, the import of which is otherwise prohibited under section 10 of the Act, may be imported for treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such disease requiring therapies for unmet medical needs, by a Medical Officer of a Government Hospital or an Autonomous Medical Institution providing tertiary care, duly certified by the Medical Superintendent of the Government Hospital, or Head of the Autonomous Medical Institution, subject to the following conditions, namely:- (a) no new drug shall be imported for the said purpose except under a licence in Form 11-A, and the said drug has been approved for marketing in the country of origin; (b) the licensee shall use the substances or drugs imported under the licence exclusively for the purpose of treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, under the supervision of its own Medical Officers at the place, specified in the licence or at such other places, as the licensing authority, may from time to time authorise; (c) the licensee shall allow an Inspector authorised by the licensing authority in this behalf to enter, with or without prior notice, the premises where the substances or drugs are stocked, and to inspect the premises and relevant records and investigate the manner in which the substances or drugs are being used and to take, if necessary, samples thereof; (d) the licensee shall keep a record of, and shall submit the said report half yearly to the licensing authority, the substances or drugs imported under the licence, together with the quantities imported and issued to the patients, the date of importation, the name of the manufacturer, the name and address of the patient for whom the drug is prescribed and the name of disease; (e) the licensee shall comply with such other requirements, if any, applicable to the holders of import licences for import of new drugs for treatment of patients by Government Hospitals, as may be specified from time to time in any rule subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than one month’s notice; (f) the drug shall be stocked under proper storage conditions and shall be dispensed under the supervision of a registered pharmacist; (g) the quantity of any single drug so imported shall not exceed 100 average dosages per patient: Provided that the licensing authority may, in exceptional circumstances, sanction the import of drug of a larger quantity.

This Chapter shall apply only to

12[Ayurvedic, Siddha and Unani Drugs Technical Advisory Board].—(1) The Central Government shall, by notification

in the Official Gazette and with effect from such date as may be specified therein, constitute a Board (to be called the

12[Ayurvedic, Siddha and Unani Drugs Technical Advisory Board]) to advise the Central Government and the State Governments on technical matters arising out of this Chapter and to carry out the other functions assigned to it by this Chapter.

1. (2) The Board shall consist of the following members, namely:— ____________________________________________________________________________________________________________

¹ Ins. by Act 21 of 1962, s. 22 (w.e.f. 27-7-1964).

² Ins. by Act 68 of 1982, s. 29 (w.e.f. 1-2-1983).

⁴ Subs. by Act 35 of 1960, s. 10, for cl. (n) (w.e.f. 16-3-1961).

⁵ Ins. by Act 68 of 1982, s. 29 (w.e.f. 15-9-1965).

⁶ Subs. by Act 21 of 1962, s. 22, for “the drugs or class of drugs” (w.e.f. 27-7-1964).

⁷ Subs. by Act 13 of 1964, s. 24, for cl. (p) (w.e.f. 15-9-1964).

⁹ Ins. by Act 13 of 1964, s. 25 (w.e.f. 1-2-1969).

¹⁰ Subs. by Act 68 of 1982, s. 2, for “

¹¹ Ins. by Act 13 of 1964, s. 26 (w.e.f. 1-2-1969).

¹² Subs. by Act 68 of 1982, s. 30, for certain words (w.e.f. 1-2-1983).

Drugs and Cosmetics Act, 1940

1. (i) the Director General of Health Services, ex officio;
2. (ii) the Drugs Controller, India, ex officio;

1[(iii) the principal officer dealing with Indian systems of medicine in the Ministry of Health, ex officio;]

1. (iv) the Director of the Central Drugs Laboratory, Calcutta, ex officio;
2. (v) one person holding the appointment of Government Analyst under section 33F, to be nominated by the Central Government;
3. (vi) one Pharmacognocist to be nominated by the Central Government;
4. (vii) one Phyto-chemist to be nominated by the Central Government; 2[(viii) four persons to be nominated by the Central Government, two from amongst the members of the Ayurvedic Pharmacopoeia Committee, one from amongst the members of the Unani Pharmacopoeia Committee and one from amongst the members of the Siddha Pharmacopoeia Committee;]
5. (ix) one teacher in Dravyaguna and Bhaishajya Kalpana, to be nominated by the Central Government;
6. (x) one teacher in ILM-UL-ADVIA and TAKLIS-WA-DAWA-SAZI, to be nominated by the Central Government; 3[(xi) one teacher in Gunapadam, to be nominated by the Central Government;
7. (xii) three persons, one each to represent the Ayurvedic, Siddha and Unani drug industry, to be nominated by the Central Government;
8. (xiii) three persons, one each from among the practitioners of Ayurvedic, Siddha and Unani Tibb system of medicine, to be nominated by the Central Government.]

1. (3) The Central Government shall appoint a member of the Board as its Chairman.
2. (4) The nominated members of the Board shall hold office for three years but shall be eligible for renomination.
3. (5) The Board may, subject to the previous approval of the Central Government, make bye-laws fixing a quorum and regulating its own procedure and conduct of all business to be transacted by it.
4. (6) The functions of the Board may be exercised notwithstanding any vacancy therein.
5. (7) The Central Government shall appoint a person to be Secretary of the Board and shall provide the Board with such clerical and other staff as the Central Government considers necessary.

1. (1) The Central Government may constitute an Advisory Committee to be called the Ayurvedic, Siddha and Unani Drugs Consultative Committee to advise the Central Government, the State Governments and the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board on any matter for the purpose of securing uniformity throughout India in the administration of this Act in so far as it relates to Ayurvedic, Siddha or Unani drugs.
2. (2) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall consist of two persons to be nominated by the Central Government as representatives of that Government and not more than one representative of each State to be nominated by the State Government concerned.
3. (3) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall meet when required to do so by the Central Government and shall regulate its own procedure.

¹ Ins. by Act 13 of 1964, s. 26 (w.e.f. 1-2-1969).

² Subs. by Act 68 of 1982, s. 30, for cl. (viii) (w.e.f. 1-2-1983).

³ Subs. by s. 30, ibid., for cls. (xi) and (xii) (w.e.f. 1-2-1983).

⁴ Subs. by s. 31, ibid., for ss. 33D and 33E (w.e.f. 1-2-1983).

For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drugs shall be deemed to be misbranded— __________________________________________________________________________________________________________________________________________________________________________________________________

Drugs and Cosmetics Act, 1940

1. (a) if it is so coloured, coated, powered or polished that damage is concealed, or if it is made to appear of better or greater therapeutic value than it really is; or
2. (b) if it is not labelled in the prescribed manner; or
3. (c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.

(1) The Central Government or a State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts for such areas as may be assigned to them by the Central Government or the State Government, as the case may be. (2) Notwithstanding anything contained in sub-section (1), neither the Central Government nor a State Government shall appoint as a Government Analyst any official not serving under it without the previous consent of the Government under which he is serving. (3) No person who has any financial interest in the manufacture or sale of any drug shall be appointed to be a Government Analyst under this section.

(1) The Central Government or a State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Inspectors for such areas as may be assigned to them by the Central Government or the State Government, as the case may be. (2) The powers which may be exercised by an Inspector and the duties which may be performed by him and the conditions, limitations or restrictions subject to which such powers and duties may be exercised or performed shall be such as may be prescribed. (3) No person who has any financial interest in the manufacture or sale of any drug shall be appointed to be an Inspector under this section. (4) Every Inspector shall be deemed to be a public servant within the meaning of section 21 of the Indian Penal Code (45 of 1860) and shall be officially subordinate to such authority as the Government appointing him may specify in this behalf.

The provisions of sections 22, 23, 24 and 25 and the rules, if any, made thereunder shall, so far as may be, apply in relation to an Inspector and a Government Analyst appointed under this Chapter as they apply in relation to an Inspector and a Government Analyst appointed under Chapter IV, subject to the modification that the references to “drug” in the said section, shall be construed as references to “Ayurvedic, Siddha or Unani] drugs”.

Whoever having being convicted of an offence,— (a) under clause (a) of sub-section (1) of section 33-I is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which may extend to two years and with five which shall not be less than two thousand rupees; (b) under clause (b) of sub-section (1) of section 33-I is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which shall not be less than two years but which may extend to six years and with fine which shall not be less than five thousand rupees: Provided that the Court may, for any adequate and special reasons to be mentioned in the judgment, impose a sentence of imprisonment for a term of less than two years and of fine of less than five thousand rupees; (c) under sub-section (2) of section 33-I is again convicted of an offence under that sub-section, shall be punishable with imprisonment for a term which may extend to six months and with fine which shall not be less than one thousand rupees.

Where any person has been convicted under this Chapter, the stock of the Ayurvedic, Siddha or Unani drug, in respect of which the contravention has been made, shall be liable to confiscation.

The provisions of this Chapter except those contained in section 33K shall apply in relation to the manufacture for sale, sale or distribution of any Ayurvedic, Siddha or Unani drug by any department of Government as they apply in relation to the manufacture for sale, sale or distribution of such drug by any other person.

(1) No prosecution under this Chapter shall be instituted except by an Inspector with the previous sanction of the authority specified under sub-section (4) of section 33G. (2) No Court inferior to that of a Metropolitan Magistrate or of a Judicial Magistrate of the first class shall try an offence punishable under this Chapter.

(1) The Central Government may, after consultation with, or on the recommendation of, the Board and after previous publication by notification in the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter: Provided that consultation with the Board may be dispensed with if the Central Government is of opinion that circumstances have arisen which render it necessary to make rules without such consultation, but in such a case, the Board shall be consulted within six months of the making of the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules. (2) Without prejudice to the generality of the foregoing power, such rules may— (a) provide for the establishment of laboratories for testing and analysing Ayurvedic, Siddha or Unani drugs;

For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drug shall be deemed to be adulterated,—

1. (a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or
2. (b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or
3. (c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or
4. (d) if it bears or contains, for purposes of coloring only, a colour other than one which is prescribed; or
5. (e) if it contains any harmful or toxic substance which may render it injurious to health; or
6. (f) if any substance has been mixed therewith so as to reduce its quality or strength. Explanation.—For the purpose of clause (a), a drug shall not be deemed to consist, in whole or in part, of any decomposed substance only by reason of the fact that such decomposed substance is the result of any natural decomposition of the drug: Provided that such decomposition is not due to any negligence on the part of the manufacturer of the drug or the dealer thereof and that it does not render the drug injurious to health.

For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drug shall be deemed to be spurious—

1. (a) if it is sold, or offered or exhibited for sale, under a name which belongs to another drug; or
2. (b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive, or bears upon it or upon its label or container the name of another drug, unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or
3. (c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or
4. (d) if it has been substituted wholly or in part by any other drug or substance; or
5. (e) if it purports to be the product of a manufacturer of whom it is not truly a product.

No person shall

manufacture for sale or for distribution any Ayurvedic, Siddha or Unani drug except in accordance with such standards, if any, as may be prescribed in relation to that drug.

From such date as the State Government may, by notification in the Official Gazette, specify in this behalf, no person, either by himself or by any other person on his behalf, shall—

1. (a) manufacture for sale or for distribution—
   • (i) any misbranded, adulterated or spurious Ayurvedic, Siddha or Unani drugs;
   • (ii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof the true list of all the ingredients contained in it; and Drugs and Cosmetics Act, 1940
   • (iii) any Ayurvedic, Siddha or Unani drug in contravention of any of the provisions of this Chapter or any rule made thereunder;
2. (b) sell, stock or exhibit or offer for sale or distribute, any Ayurvedic, Siddha or Unani drug which has been manufactured in contravention of any of the provisions of this Act, or any rule made thereunder;
3. (c) manufacture for sale or for distribution, any Ayurvedic, Siddha or Unani drug, except under, and in accordance with the conditions of, a licence issued for such purpose under this Chapter by the prescribed authority: Provided that nothing in this section apply to Vaidyas and Hakims who manufacture Ayurvedic, Siddha or Unani drug for the use of their own patients:

Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied on the basis of any evidence or other material available before it that the use of any Ayruvedic, Siddha or Unani drug is likely to involve any risk to human beings or animals or that any such drug does not have the therapeutic value claimed or purported to be claimed for it and that in the public interest it is necessary or expedient so to do then, that Government may, by notification in the Official Gazette, prohibit the manufacture, sale or distribution of such drug.