Explained | Why are Indian drugmakers under the lens? Premium

Since October 2022, Indian pharma companies have been under constant international scrutiny for exporting allegedly contaminated drugs, which have led to deaths of children.

The story so far: Since October last year, Indian pharma companies have been under constant international scrutiny for exporting allegedly contaminated drugs, which have led to deaths of children. Recently, Nigeria raised the red flag on two oral drugs; Cameroon too sounded an alarm over another cough syrup reportedly made in India when several children died. Sri Lanka called out two drugs manufactured in India linking them to adverse reactions in several patients. In the latest move, Gambia has declared that from July 1, it is running strict quality control checks on all pharma products shipped into the country, before they leave Indian shores.

Soon after Gambia reported deaths of at least 70 children related to a contaminated cough syrup made in India, in December last year, reports from Uzbekistan of at least 18 children dying after consuming cough syrup contaminated with high amounts of diethylene glycol (DEG) or ethylene glycol poured in. The pharma company, Marion Biotech’s licence was cancelled by the national watchdog — the Central Drugs Standard Control Organisation (CDSCO) — in March, but the Ministry of Health and Family Welfare has not answered any questions on the probe that was launched. A senior health official had earlier told The Hindu that the back-to-back allegations were a ‘conspiracy’ against the Indian pharma industry which is pegged at $42 billion.

The complaints from across the world on quality of Indian drugs does not seem to stop. The latest in line are alerts from Sri Lanka, where patients are reported to have died after being administered anaesthetic drugs made in India, and that an eye medication had caused visual impairment in 10 patients. Nigeria’s National Agency for Food and Drugs Administration and Control found a batch of oral paracetamol and another cough medicine manufactured by companies based in Mumbai and Punjab to be sub-standard.

While Gambia has appointed Mumbai-based Quntrol Labs to independently assess the manufacturing plants and drug samples of Indian exporters who ship drugs to Gambia from July onwards, The Hindu has learnt that it is not the first such African country to have a checking system in place. “Mozambique has been checking samples from all batches of medicines before they are exported from India to its shores,” Riddhi Jhaveri, founder of Quntrol Labs, told The Hindu. For instance, Ms. Jhaveri says, in the case of a sample of paracetamol drug — Azithromycin 500 mg — that was tested by Quntrol, it was found that there was only 20 mg of azithromycin instead of 500 mg. “We have a database of more than 500 exporters whose batch samples we analyse, and in the past several years we have picked up nearly 40 to 45 non-conformities in the samples,” said Jhaveri.

In fact, Nigeria has been more careful. Not only does the Nigerian government get all pharmaceutical samples checked, it has also mandated that samples from all batches of chemicals, food, medical devices and cosmetics be checked by an independent assessor.

The issue of contaminated cough syrup batches seeping into the supply chain and finding their way to paediatric patients is not only limited to exports. India has recorded at least five major DEG poisoning events since 1972, killing at least 84 children. The incidents occurred in Chennai, Maharashtra, Bihar, Haryana, and the latest being the 2019 case in Jammu.

Take the Jammu case for instance, where the Himachal Pradesh Drug Control Administration (HPDCA) said in court that the errant manufacturer Digital Vision did not have the proper facility to test finished products for contamination. The pharma company, however, was not in the dock for the first time. It has a poor track record of at least 19 prior violations. State Food and Drug Administration bodies are not mandated to disclose the reports of inspections conducted by them on the pharma manufacturing facilities that fall under their jurisdiction.