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CDSCO to audit manufacturing units globally, upgrade Sch M units domestically towards drug quality

Shardul Nautiyal, Mumbai
Thursday, April 20, 2017, 08:00 Hrs  [IST]

As a step towards ensuring that India retains its identity as the pharmacy of the world, the Central Drugs Standard Control Organisation (CDSCO) is planning to audit manufacturing units in both developed and developing markets globally to ensure that India gets quality drugs and ingredients from the importing countries like the US, Europe and China.

“The audits on manufacturing units are not restricted to developed economies alone as CDSCO plans to expand it to other markets from where India gets medicines to ensure drug quality and compliance,”  informed Drug Controller General of India (DCGI) Dr G N Singh.

At the same time CDSCO, as 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.

This comes at a time when Department of Pharmaceuticals (DoP) is also working on Pharmaceutical Technology Upgradation Assistance (PTUA) scheme for specific manufacturing units in the country. PTUA envisages support to medium scale manufacturing units in bulk drugs and formulation manufacturing sectors for their upgradation from Schedule M compliance to WHO GMP compliance.

According to industry leaders, PTUAS should not be restricted to simply upgradation to WHO-GMP as aspiring industries are willing to upgrade their current WHO-GMP facility and also for advancement to EDQM, MHRA, US FDA and other regulated markets to boost exports.

Regulators globally during their audit visits at Indian sites have issued in total 19 Form 483 last year as 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.

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.

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.


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