200 'high-risk' drug firms come under Indian regulator lens

Centre, states jointly assess drug manufacturers' facilities

The Central Drugs Standard Control Organization (CDSCO) is learnt to have classified more than 200 pharmaceutical companies as high-risk, in a first such move to cleanse the Indian pharmaceutical sector. CDSCO officials refused to divulge the names. Sources said the Indian authorities have taken a decision to follow the model of the US regulator (US Food and Drug Administration, or USFDA) in cracking down on pharma companies violating compliance norms.

This is also for the first time that CDSCO has joined hands with state regulators to conduct risk-based assessments of pharma companies’ manufacturing and testing facilities. CDSCO has already completed inspection of at least 135 manufacturing units and laboratories across the country in the past few weeks. 

In recent years, Indian pharmaceutical companies have increasingly come under USFDA watch for lapses in following quality standards, while manufacturing drugs for the American market, including Wockhardt and Sun Pharmaceuticals. Ranbaxy, which was subsequently acquired by Sun Pharma, had, in 2013, pleaded guilty to felony charges, of the US Justice Department, related to drug safety. Fine imposed on the company, at $500 million, was the biggest so far in the Indian pharma sector. 

So far, while international regulators, including those from the US and the UK, have been cracking the whip on Indian pharma companies exporting overseas, the domestic counterpart — CDSCO — had kept a low profile. CDSCO officials had earlier cited dearth of inspectors and infrastructure when asked why the Indian regulator failed to keep companies under check. 

India is one of the largest manufacturers of pharmaceutical products in the world, with an annual production in excess of Rs 2 lakh crore, of which 55 per cent is exported to 200 countries, including developed nations.

“This inspection has to do with companies that export drugs,” said Union health ministry official, familiar with the ongoing assessment. 

The CDSCO had earlier sought recommendations from 200 countries to help it comply with global standards. India has often been criticised for its two-tier regulatory system for pharmaceutical products. The CDSCO’s role is limited to approval and testing of new drugs. It also monitors state regulators’ licence facilities. The 36 state regulators work independent of each other. 

Since March, at least seven state drug regulators have said 27 medicines sold by 18 pharmaceutical companies are sub-standard. They cited false labelling, wrong quantity of ingredients, discolouration, moisture formation, and failing dissolution and disintegration tests. These medicines were made by Abbott India, GSK India, Sun Pharma, Cipla, Sanofi and Glenmark Pharma, among others.

“The sample in question was picked up from a location that was not in our official list for distribution. The authenticity and storage conditions of the sample cannot be ascertained. There is no issue with the quality of our product,” said Sanofi. 

“We have challenged the report on the ground the government analyst did not use the correct methodology while testing and analysing the sample,” said GSK India. It has filed for retesting the sample at the central drugs laboratory. 

Glenmark said the batch examined by the drug regulators was not made by the company. 

“There are adequate regulations but there needs to be effective implementation,” said Jagdish Dore, managing director, Sidvim Lifesciences, a Mumbai-based consultancy firm that has advised the US government on regulatory challenges in Indian pharmaceuticals. “This will require better coordination between the central and state regulatory bodies,” he added.

A parliamentary report in 2012 alleged collusion between pharmaceutical firms and officials at the CDSCO and said the regulator was both understaffed and underqualified. The CDSCO has concluded the process of recruiting 147 drug inspectors. An additional 1,195 posts were sanctioned for upgradation of its manpower and laboratories under the 12th Five-Year Plan.