Centre In Works Towards Bringing Uniform Implementation of Drug Regulations

In an effort to address the concerns raised from time to time regarding the quality, safety and efficacy of the drugs and uniform implementation of the provisions of the regulations, the central drug regulator has been contemplating a comprehensive approach through implementation of a set of measures including uniform documentation, uniformity in enforcement and uniform market surveillance.

This includes uniform implementation of document/dossier based approval for licensing of drugs across the country, uniformity in enforcement through the already initiated risk-based inspection of drug manufacturing sites, uniform implementation of market surveillance for quality monitoring in the supply chain, among others. In the 61st meeting of the Drugs Consultative Committee (DCC) held in June, 2023 deliberated these aspects and opined that the uniform implementation of document based licensing will be able to address many issues relating the quality of drugs manufactured in the country.

It was also deliberated that a specified checklist / format may be developed which can be adopted uniformly across the country. The checklist presently being used for approval of subsequent new drugs in CDSCO may be used after appropriate modification required as per the Drugs rules, 1945, said the DCC in its minutes which was published by the Central Drugs standard Control Organisation (CDSCO) lately. The committee also recommended that the Drugs Controller General (India) issue a letter advising the State Licencing Authorities to implement the documents-based licencing uniformly across the country.

The Committee deliberated that in order to optimise the allocation of resources ensuring better quality products, compliance to the good manufacturing practices (GMP) should be uniformly checked through a risk-based approach to inspections. The facilities that need to be inspected based on history of inspection, risk associated with the product, findings of past inspections, NSQ drugs etc. The discussions were in the backdrop of various reports and perspectives which raised concerns about the quality and efficacy of the drugs manufactured in the country and sold both in India and in the export markets.