Centre Can Ban Drugs Approved by DCGI: Delhi HC
New Delhi: The Centre can ban even those drugs approved by the highest drug regulatory authority, the government maintained in the Delhi High Court on Wednesday in defence of its ban on several combination drugs last month, said a lawyer present at the proceedings. The court, meanwhile, has extended by nearly two more weeks the stay on the ban of the brands using these combinations, said the lawyer, who is representing a large pharmaceutical firm in the hearings.
Justice RS Endlaw asked Additional Solicitor General Sanjay Jain, the government's counsel, what guided the Centre's decision to ban the drugs with approval from the Drug Controller General of India (DCGI). "I wish to understand how something which satisfied the parameters earlier has suddenly been banned," he said.
The centre reserved the right to ban these drugs in spite of DCGI's approval as it was conducting a legislative exercise detached from the regulator's past decisions and approvals, Jain responded, according to the lawyer. If allowing the production and sale of these drugs was against public interest, the government could exercise the wide powers of Section 26A of the Drugs & Cosmetics Act, Jain said, according to another lawyer representing a large drug maker.
Jain also told the court that the powers provided to the government by 26A were legislative in nature and the government, therefore, was not required to issue show-cause notices to the companies, said the lawyer.
The court extended the stay on the ban to April 18 and asked counsels of the petitioners to narrow down issues yet to be addressed by the government lawyer in the interim, said the first lawyer. More than 60 pharma companies approached the Delhi High Court following the health ministry’s ban of 344 fixed dose combinations (FDCs), notified in a March 10 gazette notification.