Hon’ble Delhi High Court while dealing with a petition here on 18-02-2019 in the case of “HETERO HEALTHCARE LTD. v. Union of India” stated that the provisions of Section 26A of the Drugs and Cosmetics Act, 1940 cannot be pressed into service for proscribing a therapy or packaging of the drugs in any manner.
BRIEF FACTS OF THE CASE
The petitioner manufactures and markets the Combikit under the brand name of FAS-3 KIT whereas the another petitioner was engaged in the manufacturing and marketing of a Combikit of the aforesaid combination, which is being sold under the brand name CANTRAS KIT.
The Expert Committee constituted by the Central Government did not recommend the Combikit and in view of the recommendations of the Expert Committee, the Central Government while exercising its power under Section 26A of the Act, issued 344 notifications dated 10.03.2016, prohibiting the manufacture, sale and distribution of Combikit.
Thus, aggrieved by the decision, this petition was filed.
DECISION OF THE COURT
Hon’ble Court held that the provisions of Section 26A of the Drugs and Cosmetics Act, 1940 cannot be pressed into service for proscribing a therapy or packaging of the drugs in any manner. Therefore, a notification under Section 26A proscribing the same is unsustainable.
Court further held that the Combikit cannot be sold except on a medical prescription prescribing all the three drugs, which are packed in a single strip.
Thus, the impugned order was accordingly, set aside.
Read the full Judgement Here-
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