Health Ministry sets deadline. New Rules for Clinical Trials, Cosmetics and Medical Devices

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The Union health ministry is currently working to amend on a priority basis new rules related to cosmetics for which a deadline of 2 months have been stipulated apart from the new medical device rules for which 15 days time has been stipulated, according to a senior health ministry official. Rules on clinical trials are likely to come through in one month time.

Union health ministry’s plan to amend Drugs and Cosmetic Rules and formulate Medical Device Rules got further substantiated with Union finance minister Arun Jaitley announcing in Budget 2017-18 speech its larger commitment to make drugs affordable and also enhance consumption of generic medicines in the interest of common man besides indigenising medical devices towards its accessibility at the point of care.

Formulation of a new set of medical device rules is aimed at bringing down the cost of medical devices through attracting investments and strategic partnerships as part of global regulatory harmonisation.

The Union health ministry is also planning to frame and release a draft guideline towards constant upgradation of good manufacturing practices (GMP) to align India-specific standards with global regulations. This according to a senior health ministry official will take three months time aimed at taking steps further towards global regulatory harmonisation.

Meanwhile, the Drug Controller General of India (DCGI) has also submitted a proposal to the Union health ministry to mandate upgradation of Schedule M units across the country to WHO-GMP level under the purview of drug rules towards good manufacturing practices adopted globally.

Central Drugs Standard Control Organisation (CDSCO) also plans to bring about uniformity in inspections of Schedule M units across the country as a part of its programme to upgrade Schedule M units to WHO-GMP standards.

DCGI in October 2016 proposed that the validity of licenses be made ‘perpetual’ and also that Schedule M GMP may be updated to be on par with WHO GMP. Industry had also made a submission to DCGI welcoming the same. It was suggested that while the focus of Government is on ease of doing business for industry, it would be very beneficial to the manufacturers if the same facility is allowed to manufacture different types of medicines (including for humans and veterinary) as well as ayurvedic, phytopharmaceuticals, nutraceuticals and cosmetics, as long as specific GMP approvals as required for manufacture of drugs are complied with.

The current upgradation to WHO-GMP level is being evolved around the learning from global regulatory counterparts on current good manufacturing practices (cGMP) which will help manufacturers in adopting global GMP practices.

GMP is based on a criteria involving factors such as sanitation and hygiene, qualification and validation, self-inspection, quality audits, suppliers’ audits, prevention of cross-contamination and bacterial contamination during production, training employees and personnel. Global GMP violations have hurt India’s image as an inexpensive and reliable supplier of generic drugs in international markets.

The Union health ministry had also issued the draft Medical Devices Rules 6 months ago in respect of substances covered under sub-clause (i) of clause (b) of section 3 used for in vitro diagnosis; substances that are in the nature of mechanical devices covered under sub-clause (ii) of clause (b) of section 3; and devices specified from time to time by the Central Government by notification in the Official Gazette under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940).

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