The Ministry of Health and Family Welfare vide its notification dated 26th February 2019 has introduced the draft amendment rules to amend the Drugs and Cosmetics Rules 1945 inviting suggestions/comments from the public. The changes proposed are summarised below.
An additional condition has been imposed on certain applicants who wish to obtain licences under the Drugs and Cosmetics Rules, 1945. The applicants shall be required to furnish an undertaking stating that no similar brand names or trade names exist in the market which will lead to any deception or cause confusion in the market. This condition has to be satisfied by the applicants for obtaining the following licences:
- a loan licence[i] or renewal of a loan licence from the authority in Form 25, or a licence/ renewal of the licence for the manufacture of drugs included in Schedule X in Form 25-F.
- a licence for repacking of drugs, the drugs other than those specified in Schedule C and C(1), or renewal of the licence in Form 25-B.
- a loan licence for the manufacture of drugs for sale or for distribution of drugs other than the drugs specified in Schedule C, C(1), and X in Form 25A.
- a licence (in Form 28, 28-B or 28-D) to manufacture (or renewal thereof) for drugs specified in Schedules C and C(1), [excluding those specified in Part XB and Schedule X].
- a loan licence/ renewal licence (in Form 28A or 28DA) to manufacture for sale or for distribution drugs specified in Schedule C and C1 excluding drugs specified in Schedule X or of Large Volume Parenterals, Sera and Vaccine and recombinant DNA (r-DNA) derived drugs.
- Explanation to Section 69 (A) (1) of the Drugs and Cosmetics Act, 1940- loan licence means a licence which the Licensing Authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by a licensee in Form 25.
- Draft Rules – http://egazette.nic.in/WriteReadData/2019/198746.pdf