India High Court Rules Malarial Drug Test Kits are Pharmaceutical Products

In Chennai, India, the Madras high court rules that malaria testing kits are pharmaceutical products, subject to the Drugs and Cosmetics Acts. It has ordered a detailed probe into the sale of fake malaria detection kits to city hospitals, and has asked the central and state governments to launch a campaign to spread awareness about fake drugs and medical equipment.

“We feel the public at large should be sensitized on issues … and not fall prey to spurious drugs or use of improper diagnostic materials or equipment leading to improper diagnosis,” the bench said, according to the Times of India.

Dr. C Anbarasu, who filed the petition, stated that when he placed orders for 200 malaria detection kits with Tamil Nadu Bio Medical, he received kits claimed to have been imported from Denmark, but which had been opened and repackaged. While Assistant Solicitor-General J Ravindran, representing the drug control authorities, said the company had no license to import drugs at all, the company claimed the equipment did not come under the definition of drugs and that they merely repackaged the material locally. According to them, repackaging did not amount to manufacture, and hence, there was no violation of rules.

Dismissing the claim that the test kit was not a drug and that repackaging would not amount to manufacture, the first bench said: “We are unable to accept the contention that the malaria detection kits are not drugs. We hold that malaria detection kits are drugs’ within the meaning of Section 3(b) of the Drugs and Cosmetics Act.” It further held that repackaging and labeling would amount to manufacture.

Noting that the matter required wider investigation, the judges said such investigation should be done strictly in accordance with the provisions of the act. Necessary action should be taken as early as possible, preferably within three months, the judges said.