Norms on GMPs to align with global regulations to be announced soon

The Union health ministry is in the final stages to release a draft guideline towards enhancement of good manufacturing practices (GMP) to align India-specific standards with global regulations for better product quality of pharmaceutical products. Meanwhile, the Drug Controller General of India (DCGI) had 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. This according to a senior health ministry official is aimed at taking steps further towards global regulatory harmonisation for making quality drugs and will be out anytime. For the last two years, Industry and Department of Pharmaceuticals (DoP) have jointly held a series of workshops for small and medium companies aimed at imparting technical skills and improving regulatory and quality standards of manufacturers. 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. (Reference : http://www.pharmabiz.com/NewsDetails.aspx?aid=101640&sid=2)