Drugs regulator asks states to probe adverse event complaints related to India-made drugs

India’s drugs regulator is in touch with its counterparts of all countries from where cases of serious adverse events have been reported allegedly from the consumption of India-made drugs, according to people familiar with the matter.

The people added that joint teams of central and state regulators have been conducting surprise inspections of pharmaceutical manufacturing units across the country to ensure quality of medicines is not compromised.

Of the World Health Organisation’s medical product alert against 20 pharmaceutical products, mainly syrups against fever and cough, linked to around 300 deaths globally, seven are from India. While India has hinted that some of these reports are motivated by a desire to target India’s standing as the world’s pharmacy (especially for the manufacture of generics or off-patent drugs), one of the people cited above admitted that in some cases there have been lapses by Indian manufacturers.

“Special squads have been constituted of the central and state regulators, to conduct surprise checks. At least 70 companies so far have been issued show-cause notice, of which 18 have had their licences suspended because of the lapses found in manufacturing and other relevant processes,” said a senior government functionary, requesting anonymity.

To be sure, the nature of these lapses isn’t known, and it isn’t clear whether the manufacturers involved make any of the drugs listed by WHO.

The 20 States where joint inspections have been carried out are Andhra Pradesh, Bihar, Delhi, Goa, Gujarat, Haryana, Himachal Pradesh, Jammu & Kashmir, Karnataka, Madhya Pradesh, Maharashtra, Puducherry, Punjab, Rajasthan, Sikkim, Tamil Nadu, Telangana, Uttar Pradesh, Uttarkhand, and West Bengal.

Over 200 companies will be inspected in all.

“In the first phase, inspection was conducted of 76 pharma companies. This special inspection drive by the drugs regulators will continue in coming weeks,” added the official cited above.

According to the people, the joint inspections are a part of heightened pharma surveillance measures that the government has put in place a few adverse incidents involving India-made drugs were reported globally in the past six months.

In February, the Tamil Nadu-based Global Pharma Healthcare recalled its entire lot of eye drop allegedly linked to vision loss in the US.

In Uzbekistan, 18 deaths of children were linked to a syrup manufactured by a Noida-based drugs manufacturer—Marion Biotech—in December.

And in October last year, WHO issued an alert on four cough syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup — manufactured and exported by India’s Maiden Pharmaceuticals that could have possibly linked to 70 deaths of children in The Gambia.

More recently, there are reports of serious adverse events in at least 12 people in Sri Lanka allegedly due to use of anaesthetic and ophthalmic drugs.

“All the complaints are being looked into,” said another official, requesting anonymity.

As a precautionary measure, WHO, earlier this year, issued an advisory for all manufactures, and suppliers and distributors of medical products.

Meanwhile, the Food Safety and Standards Authority of India (FSSAI) on Tuesday announced that it has launched a surveillance drive to curb the menace of spurious drugs manufactured by nutraceutical companies operating across the country. As part of this initiative, the regulatory authority has initiated its first set of drives in Himachal Pradesh, directing its regional office, North, to take immediate action against the defaulting Food Business Operators involved in the production of spurious drugs.

“As part of this drive, 21 facilities operating in Baddi, Himachal Pradesh were inspected and 111 samples have been lifted during 7th to 9th June,2023. Further, 25-30 percent of the nutraceuticals manufacturing facilities in Himachal Pradesh will be inspected by the end of June 2023. To address this issue, the CEO, FSSAI convened a meeting with major manufacturers of health supplements and nutraceuticals of Baddi...,” the FSSAI statement said.