June 15, 2023

India has launched an inquiry into an allegation that a local pharmaceutical regulator, in return for a bribe, helped switch samples of cough syrups that the World Health Organisation (WHO) had linked to the deaths of children in Gambia before the samples were tested at an Indian laboratory.

That’s according to two government officials and documents reviewed by Reuters.

In an April 29 letter to the Anti-Corruption Bureau (ACB) in Haryana state, a lawyer named Yashpal accused the state’s drug controller, Manmohan Taneja, of taking a bribe of 50 million rupees (US$605,000) from local manufacturer Maiden Pharmaceuticals to help it switch the samples before a government laboratory tested them.

Maiden’s factory is based in Haryana.

Reuters was unable to independently establish that bribes were paid.

Taneja did not respond to phone calls, messages or emails seeking comment. Maiden also did not respond. The WHO had no knowledge of the allegation.

Yashpal did not say in the letter where he got the information, or provide evidence for his claim about the syrups made by Maiden.

Contacted by Reuters, the lawyer said he had learned about the alleged bribe in the Maiden case from at least two people in India’s pharmaceutical industry, including one in Maiden, but declined to identify them for fear of retribution.

“I just want the matter investigated,” said the 38 year old, adding that he was waiting to be asked to submit an affidavit that would trigger such a probe.

He said he had started looking into Taneja last year after a pharma industry friend alerted him to another case of alleged corruption.

After the Gambia deaths became public, Yashpal started investigating more closely and spoke with 40 sources in Haryana, during which he learned of the alleged Maiden bribe.

Haryana Anti-Corruption Bureau director-general Shatrujeet Kapur told Reuters that Yashpal’s complaint would be taken forward by the additional chief secretary for health in Haryana, the state’s top health bureaucrat.

Additional Chief Secretary G. Anupama said in a text message, “Enquiry is underway” and directed Reuters to the health minister for Haryana, Anil Vij, for details. Vij did not respond to requests for comment.

Yashpal’s complaint was first reported by Hindi daily Haribhoomi, on May 17.

Haryana, located near New Delhi, has major industrial clusters. India’s pharmaceutical industry is valued at US$41 billion.

Haryana has been ruled by the same party since 2014.

Naresh Kumar Goyal, the founder of Maiden Pharmaceuticals, told Reuters in December his company did nothing wrong in the production of the cough syrup.

In February, an Indian court sentenced Goyal and another Maiden executive to 2½ years in jail for quality violations in drugs sold to Vietnam a decade ago. It gave them a month to appeal.

India carried out tests on the Maiden syrups late last year after the WHO linked them to the deaths of at least 70 children in the African country, most under 5 years old, from acute kidney injury between June and October.

Tests of samples of the syrup with help from the WHO had confirmed the presence of lethal toxins — ethylene glycol and diethylene glycol, used in car brake fluid — sparking a global hunt for contaminated medicines.

However, India’s federal drugs regulator said in December its own tests found no toxins in the syrups.

Its factory inspectors did earlier find that batches of medicine may have been incorrectly labelled, according to a notice it sent to Maiden.

It has not made clear how, in light of that, it can be sure it tested the correct batch.

Yashpal also sent his complaint to the office of Prime Minister Narendra Modi, but the PM’s Office did not respond to requests for comment.

The bribery allegation was one of about half a dozen claims of corruption by Yashpal against Taneja in the letter.

Yashpal alleged Taneja had taken bribes to approve products and issue drug licences since 2021 but did not provide any evidence.

“I want an investigation done by someone outside the health department because Taneja himself is a senior health official. It is a question of India’s reputation.”

REUTERS