Government Moves SC over Ban on Combination Drugs

New Delhi, Sept 2016:

The government has moved the Supreme Court in defense of the ban it imposed earlier this year on hundreds of fixed dose combination drugs that it alleged to be irrational, unsafe for patients and lacking scientific validation. Armed with approvals from state regulatory agencies and, in certain cases, the central drug regulator, scores of drug makers countered the decision in courts.

Its impact was felt even on well-known brands like Corex, Phensedyl, Saridon, D Cold Total and Vicks Action 500 Extra.

In simple words, a fixed dose combination (FDC) is a cocktail drug of two or more therapeutic ingredients packed in a single dose.

The government has filed a petition at the Supreme Court requesting that all cases against the order being heard in high courts across the country be transferred to the apex court and heard as a single case. The move would cut any ambiguity that could arise from differing verdicts between high courts, a government official who could not be named told ET.

"It will be saving the time of the judiciary to a significant extent once the petitions are transferred to the SC. The questions of law and such being the same, the issue can be decided quickly," said the official. "(The government) doesn't want any degree of uncertainty to be around as to the prevalence of these kinds of medicines in the market and wants an early conclusion of each one of them."

The Supreme Court is currently scrutinizing the government's application and a more definite decision on when it will be heard is expected sometime next week, the official said.

Following the ban order earlier this year, drug makers have filed at least 500 petitions against the government at around 10 high courts. The Delhi High Court, which has heard arguments from both the sides on a sizable number of these petitions, is expected to deliver a judgment on the matter.

Some industry bodies are questioning why the move was made now, while a decision on the ban of all 344 FDCs is already awaited in Delhi.

"This is a logical move, but it's too late to club all of the petitions and move it to Supreme Court after the case has already been heard in Delhi and an order is pending. The whole process has to be repeated again," said DG Shah, secretary general of the Indian Pharmaceutical Alliance (IPA), which represents several large domestic companies that had taken the legal route to appeal the order.

These include firms like Cipla and Dr Reddy's.

"After allowing various high courts to hear these petitions, this would be an enormous waste of the court's time, the advocate's time and the companies' money," he said. While some remain adamant on continuing with their products, many companies with brands occupying a large share of the market in their category have decided to phase out and stop production of the FDCs that the government found to be irrational, it was learned. For instance, a number of companies have stopped making cough and cold combinations of drugs that were notified by the health ministry and are examining options of using a single ingredient, the official explained.

The banned FDCs market was altogether valued at `3,535 crore in June, with respiratory drugs capturing 44% of the overall value, according to a study by IMS Health's market reflection report for June 2016.

Between March and June, companies like Pfizer, Macleods and Alembic had recorded a reduction in the contribution of these banned FDCs to their portfolio.Several companies with the largest share of the banned FDC market reflected a reduction in the sales of these drugs between May and June, with some seeing more than 30% drop in sales, it showed.

"Most of the companies are reconciled to the fact that (these) FDCs manufactured by them did not have the requisite approvals and the kind of testing and corroboration that was required," said the official. ET Health World