The Drug Controller General of India (DCGI) has 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 is also in line with Central Drugs Standard Control Organisation (CDSCO)'s 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.

Says Dr G N Singh, DCGI, “Government will soon make it mandatory for schedule M units to raise their standards to WHO-GMP through a notification in the interest of the public under the current provisions of the law.”

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.

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 (GMP) to help equip drug control officers with the latest GMP modalities.  Around five such training programmes concluded last year with CDSCO having conducted 17 training programmes in the preceding year to train drug inspectors on carrying out GMP inspections.

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

Over the past decade, pharma industry has invested heavily in upgrading its manufacturing plants to match international standards. Approximately 1400 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.

Regulators globally during their audit visits at Indian sites have issued in total 19 Form 483 last year as a part of their observations on data integrity. Several Indian drug makers have come under the scanner of the global drug regulatory authorities in the recent years over a range of issues like data integrity, including production quality, sanitation standards and alleged data manipulation.

Any product which does not comply with good manufacturing practices of overseas markets is being considered as adulterated and hence has the chance of losing the market, a senior CDSCO official said emphasizing the purpose of the inspection in the interest of patient safety at large.