Ref: PXL/H.O./ CIR-105/2016-17 Date: 08.01.2017
Hyderabad
To,
All the Members of Council,
Dear Sir/Madam
Subject: Form 11 and Form 29 validity extended for three years (in place of one year) with effect from 2nd Feb.2017.
We would like to inform member companies that Ministry of Health & Family Welfare wide its General Statutory Rules (G.S.R) Notification dt: 2nd Feb.2017 made few amendments in Drugs & Cosmetics Rules,1945. Changes pertaining to our industry are listed below:
|
License Type/Standards
|
Licence validity/condition(prior to 2nd Feb.2017)
|
Licence validity/Rule
(issued from 2nd Feb.2017)
|
|
1)Form 11-Test License/ Import of Drugs for examination, test or analysis
|
One year
|
Three years
|
|
2)Form29- Licence to manufacture Drugs for the purpose of examination testing and analysis
|
One year
|
Three years
|
|
3)Rule 124A: Standards for veterinary drugs. –For drugs intended for veterinary use, the standards shall be those given in the current edition for the time being in force of the [British Pharmacopoeia (Veterinary)].
|
BP for veterinary drugs
|
Omitted
|
A copy of the Gazette Notification is enclosed for your information.
Members may kindly take note of the above changes.
With regards,
Udaya Bhaskar
Director General |
