AMENDMENTS TO DRUGS AND COSMETICS RULES, 1945
Ministry of Health
& Family Welfare has published draft rules for the purpose
of amending certain provisions of Part IV of the Drugs & Cosmetics
Rules, 1945 pertaining to the Import and Registration. It has
been proposed under these rules that fees related to registration
of manufacturing site and drugs may be deposited to the notified
banks in equivalent Indian Rupees also. Registration Certificate
shall not be required to be accompanied with an application for
an import licence under the rules for the import of in-vitro diagnostic
kits and reagents, except for the diagnostic notified from time
to time under sub-clause (iv) of clause (b) of Section 3. Thus,
registration requirements would become applicable to notified
diagnostic kits, viz. HIV, HCV, HbsAg & Blood Group Sera.
Information in Schedule D (I) & D (II) may be signed by the
Authorised Agents on behalf of the manufacturers. Also, provisions
have been made for the endorsement of approved drugs as additional
items in same Registration Certificates.
Pharma Industry Associations
and various importers have requested for streamlining of certain
provisions under the amended Rules notified vide GSR no. 604 (E)
dated 24.08.2001. Administrative actions have been taken for many
of such queries and circulars in this regard have been forwarded
to OPPI, IDMA etc. for their clarifications. The members have
expressed their satisfactions for most of the clarifications.
However, certain minor changes in the rules i.e. acceptance of
registration fees in Indian Rupees; regulatory provisions for
diagnostics other than HIV, HbsAg, HCV and Blood Grouping Sera;
certain specific provisions in Schedule D (I), D (II) and in Form
41 are required to be amended for smooth functioning of new dispensation.
Objections and suggestions
to the said rules are invited from the public within 45 days for
consideration of the Government and should be addressed to Secretary
(Health), Ministry of Health & Family Welfare, Nirman Bhawan,
New Delhi.
