India urgently needs a strong Drug Controller, says medical fraternity after Gambia deaths

CDSCO and DCGI slammed over soft stance towards pharma firms; doctors seek evidence-based, foolproof system to ensure manufacture of quality medicines.

ByChetana Belagere | Sumit Jha

Published Oct 06, 2022 | 6:01 PMUpdatedOct 09, 2022 | 12:44 AM

Central Drugs Standard Control Organisation (CDSCO)

With the WHO linking four India made cough syrups to the death of 66 children in Gambia, the focus is yet again on the government’s inaction against erring pharmaceutical companies, as also the need for a strong drug controller to ensure the quality of medicines manufactured in the country.

Taking to Twitter, Vinod Scaria, scientist at the CSIR-Institute of Genomics and Integrative Biology (IGIB), said, “India urgently needs a strong drug controller authority which relies on evidence and a foolproof system to ensure the quality of medicines manufactured and distributed. How many more deaths will stir people to act?”

Soft stance of Indian drug regulators 

Indian drug regulators are known for their soft stance toward the pharmaceutical industry whenever drug-quality issues surface, say experts in the pharma and medicine industry.

“Earlier too such cases have come up, and despite reporting them, the government has not taken any action. There are no quality-checks. Definitely, everyone is compromising on quality,” said K Sunil Kumar of the Telangana Medical and Sales Representatives Union.

While the Drug Control General India (DCGI) is empowered to take action, it rarely does — at least not adequately, Sunil Kumar told South First

They are not even serious about the banned drugs that are being manufactured and supplied. Several combination drugs, which are banned in other parts of the world, are being allowed by the DCGI,” he said, citing the example of the Codeine cough syrup that is not marketed elsewhere, but is sold in India.

“It is an addictive drug and even in a country like Bangladesh, it is not allowed. In India, there are companies with turnovers of ₹400-₹500 crore just from Codeine. What can you expect from DCGI,” he asked.

Former bureaucrat EAS Sarma, who wrote to the Union health secretary on Thursday, 6 October, seeking prosecution of the promoters of pharma firms found manufacturing contaminated or spurious drugs, slammed the Central Drugs Standard Control Organisation (CDSCO) and DCGI for their inaction after WHO’s alert.

“When WHO raised an alert about the Indian manufactured cough syrup from this company, why can’t our drug authorities immediately send out a note warning the same. Shouldn’t that be the priority,” he he told South First.

Just canceling licenses will not help. This kind of act is punishable under the Indian Penal Code. Why can’t the manufacturers be punished? asked Sarma.

It is all a lobby out there

A member of Federation of Medical and Sales Representatives Association of India, who spoke to South First on condition of anonymity, cited the cases registered by CBI against CDSCO officials under multiple sections of the Prevention of Corruption Act in connection with the Phase III trials of “Insulin Aspart”, an injectable which a Bengaluru-based pharma company had proposed to import and market in India.

“There are lobbyists who work as authorities inside the office of DCGI or CDSCO. They will lobby for the company and get the sanctions done. What can you expect from these authorities?”

Sarma said that when Dolo 650 maker, Micro Labs, was accused of bribing doctors with freebies worth ₹1,000 crore, the Centre had told the Supreme Court that the existing pharma marketing practices code is adequate.

“This suggests that the Centre is trying to shield pharma companies. In the name of ‘ease of doing business’, the Centre is diluting environmental norms, which allow pharma companies to pollute and endanger people’s lives. Unless this attitude changes we may continue to lose many children, people’s lives,” he said.

Describing the pharma lobby a very “powerful” one, Sunil Kumar said: “Nothing has happened in the past, we can imagine, what kind of intervention will be from the authorities. The pharmaceutical lobbies are powerful and they will get approvals. They will not be prosecuted for quality ever.”

‘Treat this case as wake-up call’

Arguing that India not only needs stronger laws and regulatory bodies, but urging the Union Health Ministry to treat the Gambia deaths as a wake-up call, public health physician with twitter handle JayEnAar said, “This should be a serious wake-up call to authorities about the decrepit state of quality control in India’s much-vaunted pharmaceutical Industry.” His tweet:

 Dr Vijay Kumar CH, paediatrician at Hyderabad’s ESI Hospital, told South First that it is important for the drug controller to be stronger and act fairly. It must rely on evidence and take action against those who err. 

“The drug controllers in each state should work strictly and monitor on regular basis. At the distribution level and consumer level, there should be regular monitoring and removing of batches of medicine with complaints, especially at village pharmacies and hospitals. But, more importantly, the DCGI which ensure that only quality medicines are approved for distribution.”

Maiden pharma a repeat offender

The All-Indian Origin Chemists and Distributors told media that “there is no supply of Maiden Pharmaceutical Limited” drugs in India, and that they only export their products. “If any guideline is issued by the Drugs Controller General of India, we will follow those guidelines,” it said.

However, Dinesh S Thakur, a public health activist, took to Twitter and put out the data with court documents on the number of times Maiden Pharmaceuticals has erred in the past. 

“Company is a repeat offender. Cited by Kerala and Gujarat for making substandard/adulterated drugs no less than 6 times. But yeah, who cares?  As usual, CDSCO will blame the Haryana State DRA and the state will sit on it,” he tweeted.