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No Relief for Pharma Firms as Ban Order Not Revoked

The Madras HC refused to stay the ban on 344 Fixed Dose Combinations and said it disagrees with the Delhi HC.

Published: 23rd March 2016 04:46 AM  |   Last Updated: 23rd March 2016 08:51 AM   |  A+A-

CHENNAI: The first bench of the Madras High Court on Tuesday refused to stay the ban on 344 Fixed Dose Combinations (FDCs) and said it disagrees with the Delhi High Court, which had earlier granted relief to certain pharma companies.

The bench of Chief Justice SK Kaul and Justice MM Sundresh, which expressed its declination to grant the stay, however, restrained the authorities concerned from taking coercive steps against the manufacturers, stockists and agents, till the stock of the medicines are exhausted.

The Union Ministry of Health and Family Welfare had banned the 344 Fixed Dose Combinations (FDCs) by a notification on March 10 since the drug combinations does not have therapeutic justification.

No Relief for.jpgThe Federation of South Indian Pharmaceutical Manufacturers Association in Chennai had filed a petition in the Madras High Court challenging the notification. During the hearing, the association’s counsel, Vijay Narayanan, drew the attention of the bench to an order passed by single judge of the Delhi High Court passed an order which stayed the operation of the ban notification and also safeguarded the pharma companies from coercive steps.

On consideration of the matter, the bench said that it disagreed with the view of the Delhi High Court judge and was not inclined to pass an all-encompassing order. The mere fact of the sale of medicines for the last so many years ipso facto cannot call for the same to continue when an expert body has gone into this issue. As to whether all procedural formalities have been followed, the provisions of the statute would be examined in the course of the proceedings.

“We are not dealing with a perishable commodity. There is a shelf life. Further, the larger public interest would weigh in favour of not staying the effect of the notification. We, however, are inclined to give limited protection to the extent that no sale is made as per the notification.

In the meantime, coercive steps be not initiated against the manufacturers, stockists and agents, in view of the stock which would have already been manufactured,” the bench said and disposed of a miscellaneous petition from the Federation, represented by its chairman B Sethuraman.

On the main petition, the bench ordered notice and Assistant Solicitor General Su Srinivasan accepted it for Union Health Ministry and Drugs Controller General of India in New Delhi. Government Pleader STS Moorthy accepted notice for State Health and Family Welfare de

‘Act only if firms Violate rules’

The Delhi High Court stayed the ban on drug sale after the government said that the three companies (Wockhardt, Glaxo and Griffon) had obtained licence from State licensing authorities for their fixed-dose combination (FDC) medicines, which was contrary to the Drugs and Cosmetics Act and Rules. The court said the government was free to take action against sale of these medicines if there was no valid licence for their sale.

‘Not dealing with  perishable items’

However, differing from the Delhi High Court’s take on the issue, the Madras High Court while denying any relief to the petitioner, said, “We are not dealing with a perishable commodity. There is a shelf life. Further, the larger public interest would weigh in favour of not staying the effect of the notification. We, however, are inclined to give limited protection to the extent that no sale is made as per the notification.”

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