India: Proposed Amendment to Drugs and Cosmetics Rules, 1945

October 3, 2018
Indian Proposed Amendment



The Drugs and Cosmetics Act, 1940 along with the Drugs and Cosmetics Rules, 1945 (“Rules”) made thereunder regulate the manufacturing, import, circulation and trade of the drugs and cosmetics industry in India. The objective of these laws is to protect the consumers from sub-standard, illegal and harmful drugs or cosmetics and prescribe detailed procedures to be adopted for their manufacturing, packaging and sale in India.

Import of manufacture of new drug for clinical trials or marketing:

PART XA of the Rules deals with import of manufacture of new drug for clinical trials or marketing. As per the Rules for the import of new drugs, prior approval is required to be obtained from the Licensing Authority established under the Rules. The said Rule prescribes inter alia the procedures for applying for the said approval.

Permission for import of drugs:

Once the Licensing Authority is satisfied as to the safety of the drug to be imported as raw material (bulk drug substance) or as finished formulation it may issue an import permission in the prescribed forms, subject to the conditions stated therein.

The Permission as may be granted will be subject related to the condition related to composition, packaging, labelling etc. mentioned therein. One such condition is that “Specimen of the carton, labels, package insert that will be adopted for marketing the drug in the country shall be approved from the Licensing Authority before the drug is marketed.”[1]

The Draft Drugs and Cosmetics (Amendment) Rules, 2018

Recently the Central Government after consultation with the Drugs Technical Advisory Board proposed amendment to the Rules. The Draft Drugs and Cosmetics (Amendment) Rules, 2018 proposes to add another condition in the license granted under Form 45, Form 46 etc. making inclusion of package inserts in each saleable unit to be provided to the consumer compulsory. This proposed amendment appears to be in the interests of consumers as it would ensure that consumers are aware of the details and instructions accompanying the drug.

The Rules once notified are likely to come into force from January 2019.

[1]Drugs and Cosmetics Rules, 1945 Form 45/ 46- Conditions for License

For more information please contact us at :