Fresh trouble for tainted pharma firm linked with Gambia deaths in decade-old case

Two senior executives of Haryana-based Maiden Pharmaceuticals have been pronounced guilty by a local Sonepat court in a case of substandard medicine, and have been awarded a sentence of two and half years of rigorous imprisonment.

The court from the city where the drugmaker has its production facility, also asked the two employees of the company to pay a fine of Rs 1 lakh each, last week.

The sentences awarded to Director, Naresh Kumar Goel, and Technical Director, M.K. Sharma, however, have been suspended so that they could appeal against the quantum of sentence in a higher court. They have time till March 23 to make such an appeal.

The latest conviction comes in a case pertaining to the supply of substandard antacid Rantidine 150 mg, under the brand name Mantek 150, to Vietnam, in 2013.

Also read : How Maiden and other Indian pharma firms exploited WHO certification process

Moneycontrol tried reaching out to the company on February 28 to seek its comment on the latest development, but calls and messages sent to its director Vivek Goyal have not been answered.

This copy will be updated when we receive a response from the firm.

Controversy’s favourite firm?

In September 2022, the company had got embroiled in a major controversy after the World Health Organisation (WHO) issued a global alert saying three paediatric cough syrups supplied by it to the Gambia had been found contaminated with toxic impurities and had linked it to the deaths of nearly 80 children in the country.

The Indian government, however, later gave it a clean chit saying that no contamination was found in the samples tested from the batches of the drugs supplied to the Gambia, even though it had found several good manufacturing practices (GMP)-related irregularities during cite inspection.

The production of all drugs at the company’s Sonepat plant has remained suspended ever since.

Meanwhile, the WHO, has not furnished the causality assessment report sought by India in the case.

Old case

In 2013, Deepak Mittal, the Indian consul general at Ho Chin Minh City in Vietnam, had written to the Union health ministry alerting it on the country blacklisting 46 companies from India for supplying substandard drugs. Maiden Pharmaceuticals was one of the drugmakers.

“In view of the fact that a large number of Indian companies have been listed as defaulters by the Vietnamese authorities, it is requested that necessary background checks on these companies may kindly be undertaken in India to see if there are complaints against them from other countries and steps be initiated to penalise them for bringing bad name to the Indian pharma industry abroad,” the letter had read.

As part of the follow-up, state drug regulators in Haryana inspected the company’s drug manufacturing plant a few months later and had collected samples of Mantek 150 from the finished goods store of the company.

Also read : Why Indian regulators fail to prevent fatal lapses in drug manufacturing

These samples were then sent for analysis to Regional Drug Testing Laboratory, Chandigarh which pronounced that the samples were ‘Not of Standard Quality’ (NSQ).

The lab, in its report, clearly said that the said samples failed to conform to the claims made by British Pharmacopoeia in terms of “uniformity of weight and assay”.

The state drug regulator then issued a notice to the company asking it to stop the sale and distribution of the said drugs and withdraw the stock from the market immediately on September 1, 2014.

The company replied to the officials that it had not sold the batch of 61,000 tablets in question to any customer as an ‘internal Quality Control department’ had also found them to be NSQ, as per the court order.

It said that while under the Drugs and Cosmetic Rules, 1945, separate and segregated places should be provided for the storage of ‘rejected materials’ and NSQ drugs are not supposed to be kept along with finished drugs meant for sale, this rule was not followed by Maiden as observed by authorities.

The order said that this may have been done with the intention of selling the substandard drugs.

“Keeping in view substandard quality drugs in Finish Goods Store would make it clear that substandard quality medicines were kept for the purpose of its sale due to deriving undue gain and such type of substandard quality drugs were also exported, as a consequence, respondent / accused No.1 i.e. M/s Maiden Pharmaceuticals Ltd. having its Directors, i.e. respondents No.2 and 3, was blacklisted (sic),” said the order.