How Can Govt Ban a Drug Without Cancelling Licence, asks High Court

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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.
Justice Rajiv Sahai Endlaw asked the Centre while hearing over 150 petitions by pharma companies challenging government’s March 10 notification banning 344 FDCs, “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,”
The decision related FDCs 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, Cipla, P&G told the court that several state governments have issued public notices in connection with Centre’s notification and drug inspectors are enforcing them.
“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” ASG said. 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”.
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.

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