CDSCO clarifies on the term “manufacture” under the Drugs and Cosmetics Act, 1940 to include processes of altering, ornamenting, finishing, packing, labeling any drug for sale

CDSCO clarifies on the term “manufacture” under the Drugs and Cosmetics Act, 1940 to include processes of altering, ornamenting, finishing, packing, labeling any drug for sale

September 14, 2017 Industry Specific 0

In a Circular dated 9th August, 2017, the Central Drugs Standard Control Organization (“CDSCO”) has clarified that the definition of the term “manufacture” as per Clause (f) of Section 3 of the Drugs and Cosmetics Act, 1940 (“Act”), will include in relation to drugs (devices) any process or part of process for making, altering, ornamenting, finishing, packing, labeling, breaking-up or otherwise, treating or adopting any drug for the purposes of sale. It has been further clarified that the definition of the term “manufacture” will also include within its ambit processes like coating, assembling of the components, sterilization of devices etc.

In light of the above clarification on the definition of the term “manufacture”, CDSCO has mandated the requirement of obtaining manufacturing license under the Act and allied rules by entities involved in the above mentioned processes.

Source: Central Drugs Standard Control Organization.

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