Post Gambian deaths, central regulator to inspect pharma companies

Tribune News Service

Aditi Tandon

New Delhi, December 27

With the implications of the Gambian child death tragedy still lingering, India’s apex drug regulator on Tuesday commenced joint inspection of a set of drug factories across the country with the objective of weeding out spurious drugs.

Most units in unorganised sector

• A NITI Aayog document says the Indian pharma industry is quite fragmented and consists of nearly 10,500 units with the majority in the unorganised sector
• Of these, about 300-400 units are categorised as belonging to medium to large organised sector with the top 10 manufacturers accounting for 36.5% of the market share

The practice so far

• State drug controllers responsible for inspection of units
• Drug inspectors of state mandated to inspect, at least once a year, all premises licensed to manufacture drugs, cosmetics
• Have to ensure that licence conditions are met; collect samples for testing

The risk-based inspection of “identified drug manufacturing units” is being conducted after a long gap and close on the heels of a Gambian parliamentary committee seeking action against Sonepat-based Maiden Pharma which, the panel said, exported contaminated cold and cough syrups potentially linked to child deaths, as also stated by the WHO in its October 5 global alert.

Though Drug Controller General of India VG Somani informed the WHO recently that Maiden products were not found to be contaminated in tests by Indian labs, the matter is far from closed. Meanwhile, Maiden Pharma’s operations remain closed, with the ball in the DCGI’s court.

The Central Drugs Standard Control Organisation (CDSCO) today did not say which facilities it would inspect but noted that the exercise would be held in collaboration with state drug controllers. “Joint inspections are being conducted as per the standard operating procedures,” the regulator said, adding that a committee of two joint drugs controllers had been constituted to monitor the process of inspection, reporting and subsequent action and ensure compliance with the Drugs and Cosmetics Act, 1940, and Rules thereunder.

The Act provides for three yearly inspections of companies, at risk of producing spurious drugs. “The exercise will ensure high standards of quality compliance with respect to drugs manufactured in the country. An action plan for nationwide inspection of manufacturing units which are identified to be at the risk of manufacturing ‘not of standard quality’ (NSQ)/adulterated/spurious drugs was made prior to carrying out of the inspections,” the CDSCO said.

The objective of drug regulation is to ensure safety, efficacy and quality of the drugs available in the country, officials said. “Once the exercise concludes, the CDSCO and state drug controllers can issue notices to firms that are non-complaint with good manufacturing practices (GMP) under the law. Cancellation of manufacturing licence is the maximum penalty following such an exercise depending on the nature of violations,” a state drug controller said.

The action stems from the government’s urge to raise the bar for the pharma industry, currently valued at USD 49 billion.

The Indian pharma sector is the third largest globally in terms of production by volume and 14th by value. The Indian Pharmaceutical Association estimates the industry to grow to USD 130 billion by 2030.

Although among top 20 pharmaceutical exporting countries, India faces the challenge of GMP compliance by majority firms. Of the estimated over 10,000 manufacturing units in India, only 2,000 are WHO GMP approved, nearly 200 are approved by the European Directorate of Quality Medicines, nearly 1,100 have European Certificate of Suitability and about 665 are US FDA-approved.

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