DRUGS & COSMETICS ACT, 1940 RECOMMENDATIONS FOR A REVAMP

The existing Drugs and Cosmetics Act of 1940 was formed during the pre-independence era. Since then, amendments have been made to the D&C Act and Rules 1940 and 1945. However, considering the ever-evolving regulatory requirements, industry stakeholders feel that there is a need to reframe the Drugs and Cosmetics Act to make it more well-defined and align it with global regulatory requirements. They believe that it will also help in streamlining drug regulatory affairs in India

- USHA SHARMA

Draft Rules to substitute existing Schedule M to bring in GMP on par with international standards

SW DESHPANDE, FORMER JOINT COMMISSIONER, FDA MAHARASHTRA AND ADVOCATE FOUNDER, PHARMALEX

In my opinion, the Drugs and Cosmetics Act is well-drafted and has been amended from time to time with major changes in 1982 and 2008. Rules have a number of amendments and Good Manufacturing Practices are upgraded by amending Schedule M and Medical Devices Rules 2017. New Drugs and Clinical Trials Rules 2019 have been incorporated. Draft Rules will substitute existing Schedule M to bring in Good Manufacturing Practices (GMP) on par with international standards. Major industry stakeholders want many changes in the draft rules as it is apprehended that it will require huge investment leading to an increase in prices. Medium and small scale industry is likely to be affected most. It has become a fashion to criticise Acts enacted in the pre-independence era.

There is a need for a revised drug classification system

DR VARUN GUPTA, CONVENOR, DIGITAL HEALTH PLATFORMS

India has made big strides on the World Bank’s ease of doing business index and Prime Minister Narendra Modi's vision of minimum government and maximum governance. It is commendable but there is an urgent requirement to remove/amend obsolete regulations that have outlived their utility and hamper governance by creating avoidable confusion. There are many sections in the Drugs & Cosmetics Act and Rules 1940 & 1945 which needs to be identified on priority. One of them is the current classification of medicines.