Madras HC refuses to quash govt notification on drug ban

The Madras High Court today declined to stay the Centre's order prohibiting the sale and manufacture of 344 fixed dose combination drugs.
The First Bench, comprising Chief Justice Sanjay Kishan Kaul and Justice M M Sundresh, issued a notice to both the central and state governments to explain their stance on a petition filed by Federation of South Indian Pharmaceutical Manufacturers Association seeking to quash the central government notification.
The matter relates to a notification issued by the Union Health and Family Welfare Ministry on March 10 this year under section 26 A of Drugs and Cosmetics Act 1940 and Drugs and Cosmetics Rules 1945 prohibiting the manufacture, distributionand sale of the fixed dose combinations (FDCS) with immediate effect.

Senior Counsel Vijay Narayanan, who appeared for the petitioners, drew the attention of the Bench to the order passed by the single judge of the Delhi High Court which stayed the Centre's notification while preventing it from taking any coercive steps against petitioner-companies.
However, declining to concur with the Delhi High Court order, the bench said that "on consideration of the matter, we respectfully disagree with the view of the single judge of the Delhi High Court and not inclined to pass an all-encompassing order."
The Delhi High Court is also hearing a plea filed by various drug-makers challenging the ban imposed on 344 drugs in India.

The Pharma Association contended that the Centre had unilaterally and arbitrarily prohibited the sale and manufacture of the 344 FDCS produced for decades without complying with the process of natural justice.

"We are of the view that the mere fact of the sale of medicines for the last so many years ipso facto cannot call for the sale to continue when an expert body has gone into the issue."
"The larger public interest would weigh in favour of not staying the effect of the notification," the court observed.
According to Biocon and Mylan, their respective breast
cancer medications are prescribed only for metastatic breast cancer, as a single judge bench of the high court had on August 13, 2015, restrained them from selling their respective Trastuzumab medicines for early breast cancer and metastatic gastric cancer.

However, both companies claim to have approvals from DCGI to sell their respective medicines for the other two cancers also, a decision which has been challenged by Roche in its civil suit claiming "passing off" of its breast cancer drugs by the two companies.
Biocon and Mylan have taken the stand that Roche no longer holds a patent in India for Trastuzumab.