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.
This story is from the November 2020 edition of Express Pharma.
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This story is from the November 2020 edition of Express Pharma.
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