After small firms, India’s drug regulator puts big companies supplying to US, EU under scanner

New Delhi: The Central Drugs Standard Control Organisation (CDSCO), India’s apex drug regulatory authority, has requested major drug manufacturing units across the country to provide information on their exporting units, the drugs they have been exporting, and any reports resulting from plant inspections conducted by foreign drug regulators over the past two years.

These include inspections done by the US Food and Drug Administration (US FDA), European Medicines Agency and Japan’s Pharmaceutical and Medical Devices Agency, among others, ThePrint has learnt.

The move is part of an exercise launched by the CDSCO last week in collaboration with state drug administration to collate all data related to pharmaceutical companies operating in India.

“There is no centralised data as of now on the number of drug manufacturing plants, the approvals they have for drug formulations, their World Health Organisation Good Manufacturing Practices (GMP) status and details related to inspections by USFDA and regulatory authorities of other countries,” a senior CDSCO official, who wished to not be named, told ThePrint.

The action, the official said, is aimed at monitoring companies since the government wants to ensure that quality controls at drug manufacturing units in the country are strengthened.

According to information shared by the Union health ministry, there are nearly 10,500 registered drug manufacturing units in India.

Uday Bhaskar, director-general of the Pharmaceutical Export Promotion Council of India under the Union Ministry of Commerce and Industry, told ThePrint that there are 703 USFDA approved plants in the country, adding that “most of these plants also export drugs to the UK and European Union.”

Sources in two Hyderabad-based pharmaceutical companies confirmed to ThePrint that they had received notices from the CDSCO and were in the process of compiling the requested data.

ThePrint reached Drug Controller General of India Rajeev Singh Raghuvanshi via calls and text message. This report will be updated if and when a response is received.

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A checkered history

Media reports show that a number of Indian drugmakers have come under the scanner in the past year over quality issues. These include small- and medium-scale drugmakers, exporting drugs to countries in Africa, Asia, plus major companies exporting generic drugs to countries like the US.

The Union government, in response to a query in the Parliament in July this year, had said for the first time that following a complaint from Marshall Islands and the Federated States of Micronesia, the CDSCO, in coordination with Punjab drugs authority, had conducted a joint investigation at QP Pharmachem Ltd.

The drug samples drawn from the manufacturing premises for test and analysis were declared as ‘Not of Standard Quality’, it had conceded.

In April this year, the WHO had raised an alert related to a batch of cough syrup supplied by QP Pharmachem, saying it contained “unacceptable amounts of diethylene glycol and ethylene glycol as contaminants”.

Last October, the world health body had sounded a global alert warning that four cough syrups made by Maiden Pharmaceuticals could be potentially linked to the deaths of 66 children in The Gambia.

Two months later, Noida-based Marion Biotech came under the lens after Uzbekistan linked cough and fever syrups supplied by the pharmaceutical firm to the death of 18 kids.

In these cases, too, the government told Parliament, “Following the suspension of the manufacturing license, all the manufacturing and export activities of the said companies are halted”.

Responding to ThePrint’s query in June, the WHO had said that it was probing allegations of 20 substandard paracetamol and cough syrups by 15 manufacturers from India and Indonesia that may be behind nearly 300 deaths across nine countries.

And while at the centre of these controversies were small pharma companies mainly focusing on export to the less regulated markets globally, names of some big companies have also been flagged for quality issues.

In April this year, for instance, one of India’s biggest drugmaker Sun Pharma said that it had received a USFDA directive for corrective measures at its Mohali Plant.

In July, the FDA had also issued a warning letter to Mumbai based drug major Lupin for some violations.

In the same month, US’s Centers for Disease Control and Prevention (CDC) had linked Chennai-based Global Pharma Healthcare’s eye drops exported to the country (distributed in the US by Delsam Pharma) to the likelihood of a highly drug-resistant bacteria.

Following these episodes, India’s CDSCO had launched a crackdown on small and medium drugmakers in the country, raiding their plants to check on GMP compliance and control measures.

But authorities said that the move is now being expanded to include all drug manufacturers in the country.

(Edited by Zinnia Ray Chaudhuri)

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