In a boost to the pharmaceutical industry, the Delhi High Court on Thursday quashed a set of notifications issued by the Central government in March this year, which had banned the manufacture, distribution and sale of 344 fixed dose combination (FDC) drugs in India.
The bench of Justice Rajiv Sahai Endlaw in a 113-page judgment has lifted the ban on the drugs, which include well known brands like Corex cough syrup and Vicks Action 500. The bench noted that Centre had acted in a “haphazard manner” and had failed to follow due procedure required to issue such a ban.
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The Central government had claimed that the ban was in the “interest of public health” and that the FDCs should be assessed as ‘new drugs’ which require clearance from the Central government. It had argued that the ban was against the FDCs which had been “wrongly granted licences” by the state drug controllers, instead of coming to the Centre.
The bench, however, noted that the Centre had allowed the drugs to continue being manufactured instead of cancelling licences, and had asked the pharma companies to apply for licences from the Drug Controller. Further, the approvals were not considered by the Drugs Controller and 10 committees were created to consider the applications.
“Section 26A does not vest the Central government with a carte blanche to regulate, restrict or prohibit the manufacture, sale or distribution of a drug. The Central government can exercise power thereunder only when satisfied that the drug involves risk to the consumers thereof or does not have any therapeutic value or contains ingredients of which there is no therapeutic justification and that, in public interest, it is necessary or expedient to regulate, restrict or prohibit that drug. Thus, power of regulation, restriction or prohibition under Section 26A cannot be exercised in public interest, for any reason other than the drug posing a risk to consumers thereof or having no therapeutic value or no therapeutic justification,” the bench held.
“The decision on the question, whether a drug is risky or does not have therapeutic value or does not have therapeutic justification cannot be a matter of policy but has to be based on scientific technical reasons,” said the bench, which has also pulled up the government for banning the drugs without consulting the Drugs Technical Advisory Board (DTAB) or the Drugs Consultative Committee (DCC), as mandated in the provisions of the Drugs and Cosmetics Act.
Noting that the DTAB and DCC were statutory bodies created under the Act “for advising the Central and the state governments on such technical matters arising out of the administration of the Act and to carry out the functions assigned to them under the Act,” the bench has observed that “it defies logic as to why” the Central government, “would, instead of using the said machinery choose to follow another course of action.”
454 separate pleas had been filed before the Delhi High Court against the notification.
Speaking to The Indian Express, senior advocate Prathiba M Singh, who had represented over 50 companies in the case, said that the pharma industry welcomed the judgment, but was “worried” about the “way the decision was taken.”
“The government shouldn’t look at the pharma industry as an adversary. The drug regulatory mechanism in India needs to be more stable, predictable and transparent. They take knee jerk reactions which are not very well considered,” said Singh.