IN a significant ruling on December 1, a single-judge bench of the Delhi High Court overturned the decision of the Central government exercised under Section 26A of the Drugs and Cosmetics Act, 1940, to ban 344 fixed dose combinations (FDC) drugs. The ban was revoked on the grounds that the government had relied on the recommendations of the Kokate Committee for issuing the March 10 notification without taking the advice of statutory bodies such as the Drugs Technical Advisory Board, the Drugs Consultative Committee (DCC) and the Central Drugs Laboratory. The exclusion of these bodies “could not be permitted”, Justice Rajiv Sahai Endlaw said. The Drugs Controller of India and not the Central government is the licensing authority under Rule 21(b), he said. The judgment held that although the government had acted in the public interest, it seemed “to have gone about it in a haphazard manner”.
Public health activists had welcomed the ban. The FDCs examined by the Kokate Committee were found to lack any therapeutic justification and apparently involved risks to human beings. The government notification banning the sale of FDCs claimed that safer alternatives were available.
The pharmaceutical industry was obviously unhappy. Its counsel argued that the notification did not refer to any scientifically proven evidence with regard to risks to human beings caused by FDCs. In all, 453 pharmaceutical companies, including some big pharma groups such as Pfizer, Glaxosmithkline and Abbott, challenged the ban.
The Jan Swasthya Abhiyan (JSA), a representative body of public health activists and organisations working on public health, described the judgment as a huge setback “to efforts aimed at bringing a semblance of order in India’s pharmaceutical market”. According to the JSA, the FDCs banned by the government had little scientific rationale.
Ironically, the government notification was impugned on technical and procedural grounds. The government contended that the State Licensing Authorities had wrongly issued licences for FDCs between September 1988 and October 1, 2012, without the Drugs Controller of India’s approval. The court said the Centre should have taken action for the cancellation of licences. Instead, manufacturing of FDCs continued even as committees were constituted for considering applications. The Kokate Committee, “instead of considering the applications for approval, went into the aspects of risk to consumers and therapeutic value and therapeutic justification…”, the court observed. On the basis of the Kokate Committee’s recommendations, show-cause notices were issued to manufacturers.
The court observed: “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.” The bench also relied on a Supreme Court judgment ( Vincent Panikulangara vs Union of India, 1987 ), which involved the demand for a ban on 7,000 FDCs on the grounds of being injurious to public health. The court had held that “it was beyond judicial review to determine whether the FDCs… were indeed injurious to public health”.
The High Court referred to the fact that the Supreme Court found that the government did not accept the Hathi Committee report (1974), which highlighted “the havoc played by multinational corporations in the Indian scene and pleaded for nationalising the drug industry in the best interests of the Indian people”. Subsequently, a subcommittee constituted by the DCC recommended the banning of 20 FDCs in 1980-81. Despite directions from the Central Drugs Controller to State authorities to enforce the ban, the drugs were still found in the market.
Initial arguments revolved around the question whether FDCs were “new drugs” and that if they were not, whether they would require the approval of the Drug Controller. The government held that they were new drugs and that of the 344 banned FDCs, only three or four had the approval of the Drugs Controller and four or five FDCs, which found mention in the Indian Pharmacopeia, were not part of the banned list. The court did not enter the area of the legitimacy of manufacturing licences given to the pharmaceutical companies. It was pointed out that the Drugs Act did not have any substantive provision regarding controlling and regulating the manufacture of drugs. The court held that it could adjudicate on the decision-making process but not on the decision itself.
Medicines account for almost 70 per cent of health-care expenses, and the expensive FDCs would be a drain on the already sparse incomes of individuals. The JSA said some of the cough syrups listed in the ban order were used as addictive substances and not as therapeutic agents. It cited several cases filed for smuggling Phensedyl, considered an addictive cough syrup.