US-based author Katherine Eban’s book Bottle of Lies – The Inside Story of the Generic Drug Boom has put the Drug Controller General of India (DCGI) in a spot. Eban, following an investigation spanning several years, has recounted incidents of how products from Indian generic drug companies failed quality tests or had not been effective.

After the book’s release in India, the Health Ministry wrote to the DCGI, demanding to know how much truth the book carried, and what the drug quality watchdog was doing to make sure that consumers were supplied safe drugs that worked.

BusinessLine had access to a copy of the DCGI’s reply, in which the regulator said Eban’s book contained ‘fiction-filled stories of the Indian pharma industry’.

In response to BusinessLine ’s query on the DCGI allegation, Eban said via e-mail: “Everything in it is factual, verified and has not been debunked. It is based on a decade of reporting, and contains 40 pages of endnotes.”

Ranbaxy scandal

For example, Eban has closely followed the Ranbaxy scandal, where the company eventually admitted to seven felonies, including the selling of adulterated drugs — among them an anti-HIV medication to Africa, which failed to work. DCGI officials rubbished the Ranbaxy scandal as a one-off case.

“India is the largest supplier of vaccines, active pharmaceutical ingredients and finished products globally,” the regulator told the Health Ministry.

To this, Eban observed: “The events in the book extend well beyond Ranbaxy.

“They follow USFDA inspector Peter Baker and his inspections well into 2018. But there is little doubt as to the widespread incidence of fraud within Indian generic companies.

“We analysed USFDA findings from inspections over the last five years. Of all the plants cited by the USFDA for data integrity violations, 28 per cent of those plants in the US were found to have committed egregious fraud. In India, that number rose to 55 per cent, and in China, to 65 per cent. The claim that the problems in the Indian industry are a thing of the past is simply not true. Regarding trust, some generics work perfectly well. But others definitely don’t, and a culture of short-cuts and cost-cutting has harmed quality.”

USFDA’s warning letters

In 2019, the USFDA sent a record 20 warning letters to big pharma names such as Lupin, Glenmark, Cadila and Aurobindo. Warning letters are sent after companies fail to correct repeated lapses brought to their notice.

The DCGI has been on the defensive, but the truth of the matter is not everything is hunky dory in its own backyard. In a report titled ‘Drug regulation in India: The working and performance of Central Drug Standards and Control Organisation and State Drug Regulatory Authorities’, lawyers Sumathi Chandrashekharan and Shree Agnihotri have exposed loopholes in DGCI processes. They have stated that weak law enforcement has led to few prosecutions against offenders.

For example, between 2015 and 2019, there were 8,966 inspections and 1,723 instances of non-compliance in Jharkhand, but only seven cases were prosecuted. In Telangana, there were 16,675 inspections and 3,853 cases of non-compliance but zero cases were prosecuted. States are reeling under vacancies of drug inspector posts — 15-50 per cent of the posts are lying vacant across the board, the report noted.

On how companies can comply better with standards, Eban said: “Drug companies act more responsibly when they fear regulators. The problem comes when they don’t fear regulators. They may assume they can buy their way out of any negative findings, or don’t have to worry about surprise inspections. My sense, from reporting in India, is that the Indian plants don’t fear being shut down by regulators due to negative findings.”

The USFDA announces its inspections in advance, and this gives companies time to tweak their procedures at the last minute. But some still don’t make it.

“Companies must be held to the highest standards and face commercial repercussions for failing to comply,” she said.