Stringent Steps Needed To Keep India Label Safe From Fly-By-Night Operators

New Delhi: Last month, the national drug regulator’s report on not-of-standard-quality (NSQ) drugs had many worriedly check the medicines they consume.

Around the same time, though, another report emerged from Maharashtra, but did not get the national attention it deserved. Antibiotics supplied to some government hospitals in the State were found to contain nothing more than talcum powder, according to reports on an incident that had first come to light late last year.

While it’s incorrect to confuse NSQs with counterfeit or spurious products, there is nevertheless a problem at hand, which needs to be handled differently, say industry watchers.

Picking apart the three labels that are erroneously used interchangeably in common conversations, Rishi Agrawal, Co-founder and Chief Executive of TeamLease RegTech, explains that NSQ drugs involve a legitimate producer, but the product quality is affected, possibly due to a discrepancy in the manufacturing process, for example.

In a counterfeit product, the source itself is compromised and it is made by profit-making, fly-by-night operators, says Agrawal.

Spurious products bring in a different level of criminality, where the product is fake and may have little or no active ingredient.

The end-consumer is affected in every one of these cases, but they must be tackled in different ways, he says.

The other concerning takeaway from the Central Drugs Standard Control Organisation’s (CDSCO) NSQ report was the response from top industry players, including Sun Pharma, Glenmark, Alkem and Torrent, which distanced themselves from the samples, saying they were spurious or counterfeit.

A health ministry communication, dated 2017, pegs prevalence of NSQ drugs at 3.16 per cent and spurious drugs at 0.0245 per cent. But industry insiders worry about the repercussions for the industry and patients. Between the Centre mandating the use of QR codes on the packaging of key medicines to trace their journey, and individual efforts to design hard-to-replicate packaging, among other measures — efforts are on to stay ahead of unscrupulous makers of spurious products.

They concur that there cannot be shades of grey when it comes to quality, and the problem must be fixed between the industry and regulatory authorities to lend credibility to products carrying the Indian-made label.

Mahesh Zagade, former commissioner with the Maharashtra Food and Drug Administration, says the laws are stringent but the regulatory system is broken. He calls for taking regulatory officials to task if spurious drugmakers and counterfeiters are found operating under their watch. If there is a stringent watch on the supply chain — between the manufacturer, wholesaler, retailer and patient — it keeps out unscrupulous elements, he says.

Producers of spurious drugs and counterfeits should be shut down publicly so that “it sends shivers down the spine” of anyone contemplating similar activities, says Agrawal.

NSQs need to be tackled at multiple levels, including through industry-led self-regulatory organisations (SROs), he says, drawing on similar examples from the mutual funds industry. Industry platforms can also support companies in product lifecycle management, he says. For the Indian-made label to carry credibility, SROs should distance themselves from, and flag the counterfeiters and spurious producers, he adds.

However, he cautions against adding to the already high number of compliance requirements for the pharma industry. There are 998 unique compliances and 2,500 total compliances required annually from a small business with a single manufacturing unit and a single-State operation, he says. As many as 489 of the unique compliances carry a jail term, he says. Agrawal suggests creating a compliance profile — a history of compliances for each company to help separate genuine makers from outright offenders.

Another industry insider points to the competition between states in granting approvals to manufacturing units, leading to governance slip-ups. There is no harm in competition, says Agrawal, but not at the cost of a dip in manufacturing controls.

Profiteering happens at the cost of human lives, and while consumer awareness is necessary to steer clear of fake or poor quality drugs, the ultimate responsibility lies at the doorstep of the regulator, Zagade stresses. Agrawal calls for transparency in communication — on the action taken on errant companies, for example, to build trust in consumers. It is about accountability and regulatory oversight, he says, and not about pointing fingers at the origin State or mode of selling (whether online or offline), he points out.