Packing of drugs (Drugs and Cosmetics Act ,1940 and Rules, 1945)
(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 further 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 specific justification by the said Licensing Authority:
Provided also that] Oxytocin injection meant for sale shall be in single unit blister pack only:
Provided also that Diclofenac injection for human use shall be in single unit dose pack only.
Packings of drugs specified in Schedule X.- The drugs specified in Schedule X shall be marketed in packings not exceeding-
(i) 100 unit doses in the case of tablets/capsules.
(ii) 300 ml in the case of oral liquid preparations; and
(iii) 5 ml in the case of injections:
Provided that nothing in this rule shall apply to packing meant for use of a hospital or a dispensary subject to the conditions that–
(i) such supplies are made by the manufacturers or distributors direct to the hospital/dispensaries and
(ii) hospital packs shall not be supplied to a retail dealer or to a Registered Medical Practitioner.
Diseases which a drug may not purport to prevent or cure.—
(1) No drug may purport or claim to prevent or cure or may convey to the intending user thereof any idea that it may prevent or cure one or more of the diseases or ailments specified in Schedule J.
(2) No drug may purport or claim to procure or assist to procure, or may convey to the intending user thereof any idea that it may procure or assist to procure, miscarriage in women.
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube