The Madras High Court has directed the Central Drugs Standard Control Organisation (CDSCO), New Delhi, and the organisation's Assistant Drug Controller, Chennai, to proceed against a firm for importing malaria detection kits (MDK) without a licence, after affording effective opportunity to it. Necessary action may be taken as expeditiously as possible, preferably within three months.

Disposing of a writ petition, the First Bench comprising Chief Justice M.Y.Eqbal and Justice T.S.Sivagnanam held that MDKs were ‘drugs' within the meaning of the Drugs and Cosmetics Act (DCA) and rules. The firm did not possess any such licence. Prima facie it appears to be a violation of the Act and rules.

In his writ petition, C.Anbarasu, chairman, Para Medical Wing, Indian Medical Association, said Tamilnadu Bio Medical, Avvai Nagar here, did not possess a valid licence for repacking and sale of MDKs, which were said to have been imported from Denmark. The products sold by the firm were made locally by purchasing material from the local market. It had handwritten the date of expiry on the packing. The petitioner said the kits were fake and the public had been put in peril. Hence, the CBI should be directed to investigate the matter.

In its counter, the firm contended that licence was not required under the provisions of the DCA and rules. As per the policy guidelines, they were freely importable. As per the original pack imported from Denmark, the expiry date was three years. But the firm had given only six months as the date of expiry from the date of repacking. This had been done in public interest. The business had been closed down in June 2009 and no imports were made thereafter.

The Bench said repacking and labelling by the firm would fall within the definition of 3 (f) of the Act and amount to manufacture. If the outcome of the investigation revealed that indigenous kits had been passed off representing as if they had been imported, the issue was very serious. However, no material had been placed before the court to show that any case had been reported on account of any treatment being given due to wrong diagnosis by using the kits marketed by Tamilnadu Biomedical.

The court felt that the matter required deeper probe by the CDSCO. The organisation had already directed legal action to be initiated against the firm for contravening the law.

It also felt that the public at large should be sensitised by issuing public notices in newspapers and distribution of pamphlets and educating the public as to in what manner they should get themselves tested for such diseases.

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