Government has taken various regulatory measures since 2019 to ensure the quality of medicinal products in country

The Government has taken various regulatory measures since 2019 to ensure the quality of medicines in the country. The key measures are as under:

The Drugs Rules, 1945 were amended providing that every Active Pharmaceutical Ingredient (bulk drug) manufactured or imported in India shall bear Quick Response Code on its label. The stored data or information shall include the minimum particulars including Unique product identification code, Batch No, Manufacturing date, Expiry Date.

The Drugs Rules, 1945 were amended providing that any marketer who sells or distributes any drug shall be responsible for quality of that drug as well as other regulatory compliances along with the manufacturer under these rules.

The Drugs Rules, 1945 were amended providing that “in case the applicant intends to market the drug under a brand name or trade name, the applicant shall furnish an undertaking in Form 51 to the Licensing Authority to the effect that to the best of his knowledge based on search in trademarks registry, central data base for brand name or trade name of drugs maintained by Central Drugs Standard Control Organisation, literature and reference books on details of drug formulations in India, and internet, such or similar brand name or trade name is not already in existence with respect to any drug in the country and the proposed brand name or trade name shall not lead to any confusion or deception in the market”.

The manufacture for sale, sale and distribution of 80 Fixed Dose Combinations (FDCs) drugs in India were prohibited in public interest after consultation with the Drugs Technical Advisory Board.

220 additional posts of various levels have been created including Joint Drugs Controller, Deputy Drugs Controller, Asst. Drugs Controller and Drugs Inspector in the year 2022-23.

Further, Department of Pharmaceuticals has launched a scheme, namely, Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP). Under the scheme, Generic Medicines are sold through dedicated outlets namely Pradhan Mantri Bhartiya Janaushadhi Kendras (PMBJKs). It is an initiative of Government of India towards making an impact on common masses to provide quality medicines at affordable prices. As on 30.06.2022, 8,742 Janaushadhi Kendras have been opened across the country and the product basket of PMBJP comprises 1,616 drugs and 250 surgical items.

The Union Minister of State for Health and Family Welfare, Dr. Bharati Pravin Pawar stated this in a written reply in the Rajya Sabha today.