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Health ministry to give final touches to norms on GMPs to align with global regulations

Shardul Nautiyal, Mumbai
Thursday, April 27, 2017, 08:00 Hrs  [IST]

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.

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.

GMPs 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.

CDSCO has successfully concluded training sessions for drug inspectors in the past one year on risk-based inspection and good manufacturing practices to help equip drug control officers with the latest GMP modalities.

At the same time CDSCO, as a part of its larger commitment towards harmonisation of global regulatory standards, is on its way to step up audits in the manufacturing units across the country for compliance with GMP as per the requirements of the respective regulated markets.

Approximately 1,400 manufacturing units in India are WHO GMP certified, and over 800 are UK MHRA approved. India continues to have the highest number of US FDA registered manufacturing facilities outside the US. The industry has strong capabilities in product development. Also, Indian pharmaceutical companies have the largest share of DMFs and ANDAs outside the US.

 

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