CDSCO begins enforcement drive to curb poor quality drug manufacturing practices in India

Central Drugs Standard Control Organisation (CDSCO) has initiated a major nationwide enforcement drive to curb poor quality manufacturing, in a bid to ensure that medicines produced in India are as per WHO prescribed GMP norms so that the country continues to be the pharmacy of the world.

"Drive includes action against drugs, public testing labs and clinical research organisations as CDSCO has actioned pan India inspection on various categories of medicines," sources aware of the matter told CNBC-TV18.

As per the directions, "Enforcement teams have been asked to pickup random samples from manufacturing premises under detailed inspection drive from categories such as: FDC, vaccines, syrups, complex formulations, Bulk Drugs etc," sources said.

According to sources, the ongoing enforcement drive by CDSCO is a joint operation between centre and states. "Top government has asked CDSCO to undertake drive to ensure India doesn't lose trust among global markets," sources said.

Government wants that the Indian pharma companies should raise standards of manufacturing processes to global level.

In the past, India has become the manufacturing hub of pharmaceuticals helping to sustain the medicinal requirements of the world, the top government feels that it is now necessary for the Indian companies to raise the standards of manufacturing processes.

The enforcement move comes in the wake of concerns being raised recently by regulators of foreign countries over the quality of Indian made pharmaceuticals.

"Since January this year, the Indian government has received 18 international alerts, which has become a serious concern," sources shared.

Noting this, the government wants manufacturing units to constantly upgrade themselves to meet the good manufacturing practices (GMP) norms prescribed by WHO.

India is currently supplying pharmaceuticals to around 200 countries.

"To ensure quality standards are maintained, CDSCO has started risk-based inspections at the production sites of manufacturing companies as WHO and the US FDA were raising alarm bells to the Indian government about the quality of the Indian made drugs," sources said.

"Samples found to be "not of standard quality" (NSQ) to be sent for further testing at Central drug laboratory (CDL) Kolkata for final analysis. The current enforcement drive is to ensure production, verification and validation of manufacturing Standards being followed. There are clear instructions issued by the CDSCO directing enforcement teams to take legal actions for in compliances like NSQs," sources added.

"In the case of public testing labs, complaints had been received and noting the same, enforcement teams found that the public testing labs and the private labs do keep the accurate data of the analysis when they are asked to show data during the government audit and inspections," sources said.

"The top government is of the view that the Industry should adhere to implementing WHO prescribed GMP norms. Industry should focus on avoiding recalls. Meeting the quality norms will in turn help the industry to maintain safety and quality of products and reduce risk of cross contamination, adulteration, mislabeling," sources added.

It is important to note that the enforcement action is part of risk based inspection to ensure Good Manufacturing Practice norms are met. Also, government had initiated this Risk based inspection way back in 2016-17 and thus felt the renewed need for a fresh assessment.

According to recent reports, since last 10 months, over 236 companies were audited and over 220 show-cause notices were issued by CDSCO. In addition, 76 stop-production orders have been given.