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CS Executive · Setting Up of Business, Industrial and Labour Laws · Identifying Laws applicable to various Industries and their Initial Compliances

Ravi Pharma Pvt Ltd intends to manufacture allopathic tablets for sale in India. Which statement correctly identifies the industry-specific law governing its manufacturing activity?

Manufacturing allopathic tablets requires a manufacturing licence under the Drugs and Cosmetics Act, 1940 and its rules. General registrations such as shops and establishments do not substitute for it, and food or petroleum legislation concerns different products.

  1. AA manufacturing licence is required under the Drugs and Cosmetics Act, 1940 and the rules made under itCorrect
  2. BOnly registration under the Shops and Establishments law is needed
  3. CA licence under the Food Safety and Standards Act, 2006 is the principal requirement
  4. DThe Petroleum Act, 1934 governs the manufacture of tablets

Explanation

Manufacture of drugs requires a licence from the licensing authority under the Drugs and Cosmetics Act, 1940 and its Rules. Shops and establishments registration is a general local compliance and does not replace the drug licence. The food law and petroleum law cover other products.

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