Packing of drugs.

(1) The pack sizes of drugs meant for retail sale shall be as prescribed in Schedule P1 to these rules. (2) The pack sizes of drugs not covered by Schedule P-1 shall be as given below: – Unless specified otherwise in Schedule P-1, (i) The pack sizes for Tablets/Capsules shall be– Where the number of Tablets (coated or uncoated)/Capsules (hard or soft gelatin) is less than 10, such packing shall be made by the integral number. For numbers above 10, the pack size of Tablets/Capsules shall contain multiples of 5. (ii) The pack sizes for liquid Oral preparations shall be 30 ml (paediatric only)/60 ml/100 ml/200 ml/450 ml. (iii) The pack sizes for Paediatric Oral Drops shall be 5 ml/10 ml/15 ml. (iv) The pack sizes for Eye/Ear/Nasal drops shall be 3 ml/5 ml/10 ml. (v) The pack size for Eye Ointment shall be 3 gm/5 gm/ 10 gm: Provided that the provisions of the pack sizes covered under this rule shall not apply to: – 1. Pack sizes or dosage forms not covered by the foregoing provisions of this rule. 2. The imported formulations in finished form. 3. Preparations intended for Veterinary use. 4 Preparations intended for Export. 5. Vitamins/Tonics/Cough Preparations/Antacids/Laxatives in Liquid Oral forms, Unit dose (including applicaps). 6. Pack sizes of dosage forms meant for retail sale to Hospitals, Registered Medical Practitioners, Nursing Homes. 7. Physician’s Samples. 8. Pack sizes of large volume Intravenous Fluids: Provided also that pack sizes of any of the new drug as and when approved by the Licensing Authority appointed under Rule 21 and if not covered under this rule, shall be examined for the purpose of approval with the specific justification by the said Licensing Authority: Provided further that Oxytocin injection meant for sale shall be in single unit blister pack only: