Section 33 of DCA : Section 33: Power Of Central Government To Make Rules

Explanation using Example

Imagine a pharmaceutical company, "HealthPlus Pharma," is planning to introduce a new antibiotic drug to the Indian market. Before they can proceed, they need to ensure that their product complies with the regulations set out by the Central Government under the Drugs and Cosmetics Act, 1940. Specifically, they must adhere to the rules formulated under Section 33 of the Act.

As per these rules, HealthPlus Pharma must:

• Have their drug tested and analyzed at an established laboratory to confirm it is of standard quality (as per rule (a))
• Ensure that the drug packaging includes the date of manufacture and the expiry date, and that it is not sold after the expiry date (as per rule (h))
• Comply with the prescribed methods of test or analysis to prove the drug's quality (as per rule (c))
• Adhere to the rules regarding the labelling of the drug, ensuring that it does not claim to prevent or cure diseases or ailments not specified by the regulations (as per rules (j) and (f))
• Apply for the appropriate license for manufacturing and selling the antibiotic, following the conditions provided for such licenses (as per rule (e))

If HealthPlus Pharma fails to comply with any of these rules, they could face the cancellation or suspension of their license as well as other penalties prescribed by the Act.