1. How can govt ban a drug without cancelling licence, asks High Court

How can govt ban a drug without cancelling licence, asks High Court

Delhi High Court today observed that power given under the Drugs and Cosmetics Act to prohibit their manufacture in public interest could only be regulatory in nature and asked how could the Centre invoke this provision without cancelling the licence given to manufacturers.

By: | New Delhi | Published: April 4, 2016 9:43 PM
The government clarified that their initial concern was regarding licences being granted by states for manufacture of FDC drugs, but by the time a final decision was taken, the focus shifted on safety of such medicines.(Reuters)

The government clarified that their initial concern was regarding licences being granted by states for manufacture of FDC drugs, but by the time a final decision was taken, the focus shifted on safety of such medicines.(Reuters)

Delhi High Court today observed that power given under the Drugs and Cosmetics Act to prohibit their manufacture in public interest could only be regulatory in nature and asked how could the Centre invoke this provision without cancelling the licence given to manufacturers.

“Section 26A (powers of central government to prohibit manufacture, etc., of drug and cosmetic in public interest) appears to be only a regulatory power as per the scheme of the Act. There is no other regulatory power.

“So after you have granted licence, the only power is to cancel the licence. So can you invoke the regulatory provision without cancelling the licence,” Justice Rajiv Sahai Endlaw asked the Centre while hearing over 150 petitions by pharma companies challenging government’s March 10 notification banning 344 FDCs, a decision which has been stayed by the judge in each case filed before him since March 14.

The query was posed to Additional Solicitor General (ASG) Sanjay Jain after he said the March 10 decision was taken in public interest under section 26A of the Act.

The ASG said that “irrespective of licence, if a drug or FDC has no therapeutic justification, then it has to be banned. There is no question of cancelling the licence. Administrative process of cancelling licence will go on and on and during that time the drug will continue to be sold in the market”.

On the point of therapeutic justification, the ASG said often a patient may not require one of the ingredients in an FDC, yet he would have to take the medicine as it comes as a combination.

Meanwhile, pharma majors like Pfizer, Glenmark, Procter and Gamble and Cipla, told the court that several state governments have issued public notices in connection with Centre’s notification and drug inspectors are enforcing them.

When this issue was put to the ASG, he said Centre would issue necessary instructions to state governments informing them of the stay order and added that the companies would also have to approach the states in their individual capacity.

He also added that the Centre cannot say what will happen in Tamil Nadu where the Madras High Court has refused to stay the notification.

During the hearing, the court observed that it appeared that the mandate of the expert panel which had recommended banning of certain FDCs, was not to take action under section 26A and added “we are concerned with whether the procedure adopted (to ban the FDCs) was correct or not”.

To this, ASG Jain said the “terms of reference of the panel indicates that it was to test the safety and efficacy of FDCs which pertains to section section 26A”.

He questioned the basis of the pharma majors’ claims that the expert panel lacked statutory backing, “especially when they have participated with the committee”.

He said the companies and their various groups, like the Indian Drug Manufacturers’ Association (IDMA), were aware of the exercise being carried out by the Kokate panel and that it was dealing with safety, efficacy and rationality of FDCs.

He further said the companies had earlier not raised the issue of the panel’s credibility, despite several opportunities to do so, and was doing it only now.

The Centre on March 31 had told the court that the decision to ban 344 FDCs was taken keeping in view “safety, efficacy and rationality” of these medicines.

The government, however, clarified that their initial concern was regarding licences being granted by states for manufacture of FDC drugs, but by the time a final decision was taken, the focus shifted on safety of such medicines.

Earlier, the drug firms had argued that the Centre’s ban on the 344 FDCs was taken without considering clinical data.

The companies had also termed as “absurd” the Centre’s claim that it took the decision to ban the FDCs on the ground that safer alternatives were available.

Pursuant to the court’s interim stay order, some well- known medicines on which the ban on sale was lifted were Pfizer’s Corex cough syrup, P&G’s Vicks Action 500 extra, Reckitt Benckiser’s D’Cold, Piramal’s Saridon and Glenmark’s Ascoril and Alex cough syrups.

The March 10 notification says: “on the basis of recommendations of an expert committee, the central government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition of manufacture for sale, sale and distribution for human use of said drugs in the country.”

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