Asserting that India follows a zero-tolerance policy on spurious medicines, Union Health Minister Mansukh Mandaviya has said 71 companies have been issued show-cause notices following reportsabout deaths due to contaminated cough syrups made in the country, and 18 of them have been asked to shut shop.
In an exclusive interview with PTI Video, the Minister also said an extensive risk-based analysis is done continuously to ensure the production of quality medicines in the country, and the government and regulators are always alert to ensure that no one dies due to spurious medicines.
“We are the pharmacy of the world and we want to assure everyone that we are the ‘quality pharmacy of the world’,” he said.
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 At least 70 and 18 children in Gambia and Uzbekistan, respectively, last year.
India exported cough syrups worth $17.6 billion in 2022-23 as against $17 billion in 2021-22. Overall, India is the largest provider of generic drugs globally, supplying over 50% of global demand for various vaccines, about 40% generic demand in the U.S. and about 25% of all medicines in the U.K.
"We need to get into facts whenever 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," Mr. Mandaviya said.
He said, "We checked the samples of one company. We tried to find out the cause of death and we found that the child had diarrhoea. If a child had diarrhoea, who recommended cough syrup for that child?" 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 continuously 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.
Mr. 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 control–related concerns raised globally about 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.