It's wait and watch for pharma industry

The Union government invoked its power under Section 26A of the Drugs and Cosmetics Act, 1940 (Drugs Act), to ban 344 fixed drug combinations (FDCs) for larger public good. The impact was such that as many as 454 petitions were filed in the Delhi High Court seeking immediate revocation of the ban.

The pharmaceutical firms – small, medium and big – were looking at the high court to stop the government and the Drugs Controller General of India (DCGI) from prohibiting the manufacture, distribution and sale of these drugs in the country. Several popular medicines such as Corex – sold since 1989 – too were banned, with the government questioning the quality and therapeutic value of some of the FDCs.

The government had constituted a committee under the chairmanship of Dr C K Kokate, vice-chancellor, KLE University, Belagavi, Karnataka, in September 2014, to examine the safety and efficacy of these FDCs. Later, the Centre made the recommendations of Kokate panel report as the basis for its decision to ban the 344 drugs.

“Everyone, including the big guns, be it Pfizer or Cipla, were hit overnight. At the time the ban came, these products accounted for roughly about Rs 4,000 crore, or 4% of the Indian pharma business, annually. More than this turnover, the worry was that banning of 344 products could be the beginning,” says a medium-sized pharma unit owner. The bigger worry, drug manufacturers say, was if the government decided to revisit all the 6,000 formulations that are being scrutinised by different government panels. It would add a completely new dimension and a new way of doing business.

The drug manufacturers claim, which also was part of their contention before the court, that they follow the rules and regulations laid down by the government.

Moreover, all their products, including the banned FDCs, were sold in the market only after filing requisite data and obtaining statutory approvals. “None of the product is available in the market without permission from the government. Then how can we sell products that could potentially harm humans?” a drug manufacturer said.

So when the court turned down the Centre’s plea and questioned the manner in which the ban was imposed, many drug manufacturers heaved a sigh of relief. The court has given a temporary breather, helping people with stocks to minimise their financial loss. But they are unlikely to begin manufacturing of the banned drugs immediately. They are almost certain about the Central government approaching the Supreme Court and they would rather wait and see if it would stay the high court judgment or let them manufacture till it completes the hearing.

Some manufacturers also maintain that there is nothing wrong with their product and they would fight the legal battle. “The issue, however, is of brand value. Many of these brands have been built over the years and with a lot of investment. One cannot afford to see the value of a brand become zero overnight,” says a drug maker.

Stuck in between
The trouble is that many of the FDCs that were in the market were approved by state authorities and not the Central authority. “The problem is the Centre wants to have a say in this critical sector and we are stuck in between,” a manufacturer claimed. Some voices within the industry believe that the move could eventually prove beneficial for the industry. They say that some of the products that have been selling for over two-and-a-half decades and their periodical review in the wake of new data available could be a positive step.

“Medical science has come a long way in the last 30 years. Today, we are able to gather quality data. If we find that the drug requires a different formulation for better results, it would only help keep confidence of the people. But it is an extremely technical issue and would be best if it is looked into by experts,” said Viranchi Shah, chairman of the Indian Drug Manufacturers’ Association (IDMA) – the representative body of pharma companies.

Shah said this is not the first time that the issue has been debated within the industry or the government. “This has been debated in the country for sometime now. It is obvious that on some issues, regulators have one view and the industry has a different view. However, there are some issues where both are thinking on the same platform. The need is to find solution to the grey areas,” he adds. He opines that as the case is sub judice, the pharma players are in a wait and watch mode. “In the end, we hope something good will emerge out of this,” Shah added.
DH News Service

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