The Union Ministry of Health & Family Welfare has heeded to the request of the drug importers to pay the registration fees related to registration of manufacturing site and drugs in foreign currency of equivalent value. It has also relieved the importers from the task of producing the registration certificate along with applications for import license.
The ministry has come out with a draft notification proposing that fees related to registration of manufacturing site and drugs may be deposited to the notified banks in equivalent Indian Rupees also. It has been proposed under these rules that 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.
The amendment is expected to clear even the minor problems raised by the pharma associations. Any suggestions pertaining to the proposal to amend the provisions of Part IV of the Drugs & Cosmetics Rules, 1945 dealing with the Import and Registration should reach the government within 45 days.