The Kerala High Court in a recent judgement ruled that the court was not a competent authority to determine whether food supplements could be regarded as drugs or not and it is up to the experts to decide it.

Further, the court opined that the complainants should prove their claims before competent forums, if they have grievances on the act of the officials.

Sources told Pharmabiz that with this judgment, the companies booked by the state drug control department for allegedly selling drugs as food supplements might have to prove their claims before the lower courts by going through the routine legal proceedings, instead of securing immediate stay from various courts to continue sale of their products.

It may be noted that about two dozen cases are still pending with the High Court and Lower Courts in the state for the last four years, following the Kerala drug control department's decision to book all the firms that violate Rule 18 (C) of the Drugs and Cosmetics Act, by which the firms require a valid manufacturing and marketing license to sell products that qualify to be called as a 'drug'. Most of the companies had immediately secured stay from the courts to continue sale of their products.

"This judgment shows our contentions have been accepted by the court. Further, it is a reassurance on our powers as the drug control authority," said T P Gopinathan, Drug Controller, Kerala and M P George, Asst. Drug Controller, who heads the initiative in Kerala against food supplements with therapeutic claims.

Disposing of a writ filed by the Parry Nutraceuticals of Chennai to allow their products to be sold in the Kerala market as food supplements, a division bench of the Kerala High Court consisting of Justice K S Radhakrishnan and Justice MN Krishnan said, "We make it clear if any proceedings are initiated in any forum, it is always open to the writ petitioner to argue all those contentions in that forum, including the contention that the item seized were not drugs and it is that forum to decide the issue." This court, under Article 226 of the Constitution of India, is not justified in expressing any opinion either way since that issue has to be left to the experts, Court opines.

The state drug control department took a case against Parrys Nutraceuticals, part of the Rs 5000-crore Murugappa group, for selling the popular Spirulina, Natural Beta Carotene and Multinal in the Kerala market, during early 2002. As per the case 10/84/2002 OP N.1054, the High Court allowed a stay on the ban imposed by the state. On hearing before the single bench on 27.03.2002, the court directed the government to test the seized samples and submit the report. As per this, the seized samples were sent to the state drug control laboratory in Thiruvananthapuram for analysis.

Interestingly, the report of the government analyst favoured the company. "As perusing the label of the above two date expired items, it is noticed that they are dietary supplements and not drugs. No active ingredient is specified on the label. Certain food products have ingredients, which possess pharmacological actions also. The ingredients of the item are not included in any official pharmacopoeia available here. These items cannot be analyzed and opined without official monographs," said the analysis report.

Since the case started, the government counsel contended that the drug control department is the only authority and expert to determine whether a food supplement can be termed as a drug or not. A drug analyst is not competent to determine whether a product is a drug or not, except for checking the quality parameters and the ingredients. When the case came before the division bench two weeks ago, the court accepted the views of the drug control department, and directed the petitioner to approach a lower court to convince it of their claims.