Natco recall a case to bolster drug control

Pitfalls in the Indian drug regulations came to light last week when it was reported that a newly launched anti-cancer drug was asked to be withdrawn by the Drug Controller General of India as it failed to pass through certain tests required to certify the drug as safe.

Natco Pharma of Hyderabad, a company which has grown on the back of clones of oncology drugs, had submitted for a licence to market a product claimed to be a copy of Abraxane.

Abraxane, which uses nanotechnology to deliver a known active compound paclitaxel into the cancerous tumor, is a product developed by Abraxis headquartered on the West Coast of USA. While paclitaxel is copied by several Indian drug makers, the use of albumin as a vehicle for the active substance is a new thought. The product has therefore won approvals in the US, EU and also most recently in China.

Abraxis and its Indian partner Biocon are not leaving the opportunity of marketing a novel drug at a high cost. That is a business decision and there is no questioning it as long as there is a market for the product. But high prices of newly introduced drugs have given Indian companies an opportunity to enter a segment and bring down the prices, thereby making money, while benefiting the patients who could not afford cancer treatments. That logic applied to Natco, too.

In its quest to break new ground in cancer products, Natco copied the product and with the necessary data approved by the Indian regulators, launched it. According to the reports, the drug controller cleared the drug and the product was brought into the market.

Like every business competition, Abraxis or Biocon may not have liked the entry of a new local player with a lower price tag cloning their product Abraxane. On getting a complaint, the drug controller ordered for a retest and found that Natco’s product had a higher percentage of substance that cannot be permitted.

This fortified the government to order for a recall but this exercise was not completed before Natco’s product could be allowed into Indian market.

Natco has claimed in news reports that it wants the drug to be tested in an independent laboratory. Nothing wrong with that and it reflects the company’s confidence about the safety of the drug.

But the bigger question is how the product passed muster in the first place when the same regulator gave the approval a few months ago? Also, who takes responsibility for the patients who may have suffered due to the product? Does ordering a product recall abdicate the regulator or should stringent laws govern lapses of government authorities allowing unsafe drugs into the market? Should drugs brought in by multinational companies be monitored for pricing?

Though this is a rare example in India, drug recalls are a known practice in the developed markets though these are also followed by penalties. India cannot be matched head-to-head with those countries.

In critical therapies such as cancer, Indian patients end up spending all that they have and come with very little knowledge of how a drug works. The doctor is seen as a god and what he says is regarded as divine. This makes it even more important for the regulators to keep a vigil on products marketed in India.

Oncology is seen as one of the few segments seeing rapid growth in emerging markets. Many multinational companies are trying to keep their monopoly intact in these markets. It will be for the drug regulators like the DCGI and the National Pharmaceutical pricing Authority to see that the drugs are safe and are affordably priced.

Future medicines are likely to be extremely complex. Those will use new active ingredients, new devices and several testing methodologies. We are already seeing a few products used only on a certain set people bringing in the concept of personalised medicines.

These drugs will need a well-equipped and an extremely responsive drug regulator. Indian drug investigators have made a good start in working with the USFDA closely, but that apart, the systems will need investments of several more millions to enable the machinery to work at its best.