Cough syrup row: Zero tolerance on spurious medicines, 71 firms issued notices, says Health Min Mandaviya

Union Health Minister Mansukh Mandaviya emphasised that India maintains a strict stance against counterfeit medications, leaving no room for compromise. In response to concerns surrounding reported fatalities attributed to contaminated cough syrups manufactured in India, the minister revealed that show-cause notices have been issued to 71 companies. Out of these, 18 companies have been directed to cease their operations. During an exclusive interview with PTI, the minister further highlighted the ongoing implementation of a comprehensive risk-based analysis to ensure the consistent production of high-quality medicines within the country. The government and regulatory bodies remain vigilant and committed to preventing any loss of life caused by counterfeit drugs.

“We are the pharmacy of the world and we want to assure everyone that we are the ‘quality pharmacy of the world’,” he said.

Earlier in February, Tamil Nadu-based Global Pharma Healthcare recalled its entire lot of eye drops. Before that, India-made cough syrups were allegedly linked to the deaths of 66 and 18 children in Gambia and Uzbekistan, respectively, last year.

India exported cough syrups worth USD 17.6 billion in 2022-23 as against USD 17 billion in 2021-22. Overall, India is the largest provider of generic drugs globally, supplying over 50 per cent of global demand for various vaccines, about 40 per cent of generic demand in the US and about 25 per cent of all medicines in the UK.

“We need to get into facts whenever some questions are raised about Indian medicines. For example in Gambia, it was said that 49 children have died. Someone at WHO had said it and we wrote to them asking what the facts are. No one got back to us with the facts,” Mandaviya said.

“We checked the samples of one company. We tried to find out the cause of death and we found that the child had diarrhea. If a child had diarrhea, who recommended cough syrup for that child?” he said.The minister further said that a total of 24 samples were taken, of which four failed. “The question is if there was just one batch made for exports and if that fails, all samples would fail. It is not possible that 20 samples are passed and four samples fail. Still, we are alert. We are continuing doing risk-based analysis to ensure the production of quality medicines in our country,” he said.

From June 1, India has made tests mandatory for cough syrups before they are exported. Cough syrup exporters will have to produce a certificate of analysis issued by a government laboratory before it is exported, effective June 1, the Directorate General of Foreign Trade (DGFT) said in a notification last month.

Mandaviya said, “We have conducted risk-based analysis at more than 125 companies and our squads have visited their facilities. Of these, 71 companies have been served show-cause notices and 18 have been given closure notices.”

“I want to assure the world through you that India will never do any bargain with the quality of medicines. We follow a zero-tolerance policy. Spurious medicines would be treated the same way in the country as it is done abroad. We are always alert to ensure that no one dies because of spurious medicines,” he added.

The change in the export policy followed quality concerns raised globally for cough syrups exported by Indian firms.

Following the order, the Drugs Controller General of India (DCGI) also asked the specified states and central laboratories to test the samples received from the manufacturers of cough syrups for export purposes on “top priority and issue the test report at the earliest”.

The specified central government labs include Indian Pharmacopoeia Commission, regional drug testing lab (RDTL – Chandigarh), central drugs lab (CDL – Kolkata), central drug testing lab (CDTL – Chennai Hyderabad, Mumbai), RDTL (Guwahati) and the NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited drug testing labs of state governments.

Globally, India ranks third in terms of pharmaceutical production by volume and 14th by value.

The Indian pharmaceutical industry is a prominent manufacturer and exporter of medical products to the entire globe, ranging from highly developed countries to low and middle-income countries (LMIC).

The industry includes a network of 3,000 drug companies and about 10,500 manufacturing units. It facilitates the availability and supply of high-quality, affordable and accessible medicines around the world. India enjoys an important position in the global pharmaceuticals sector.

Inputs from PTI