REGULATORY AFFAIRS / DRUG CONTROL MATTERS

Various issues of policy or operational nature relating to the structure and implementation of the Drugs Cosmetics Rules at Central or State level are taken up with the authorities through representations and follow-up meetings. Some of the important issues which have been taken up with the authorities in recent times are :-

  • Extension of validity of WHO-GMP certificates to five years.
  • Six months grace period needed for implementation of overseas pharmacopoeia.
  • IDMA’s representation on DTAB.
  • Decentralisation of work regarding registration for import of drugs.
  • Delay in testing of drugs
  • Licence/inspection fees for SSI sector.
  • Reduction in 4 years period for treating a drug as ‘new’ drug.
  • Adoption of manufacturer’s method of analysis in case of dispute.
  • Menace of spurious drugs. Etc.



    • REVISED SCHEDULE 'M' ON GMP

    The Ministry of Health and Family Welfare has revised the Schedule ‘M’ on Good Manufacturing Practices appearing in Drugs and Cosmetics Rules, 1945 vide notification no.GSR 894(E) dated 11th December 2001.

    The Association has submitted its observations/suggestions on the provisions of the revised schedule drawing authority’s attention to the clauses which need amendments, the clauses in which inadvertent contradictions were noticed and clauses on which guidelines/clarifications were required.

    The Ministry of Health & Family Welfare has now extended the cut off date of revised Schedule M on Good Manufacturing Practices by one year i.e. up to 31.12.2004 and the provisions of the revised Schedule M will be made applicable with effect from 01.01.2005 in case of manufacturers licensed prior to 11.12.2001.


    PHARMACEUTICAL ANALYSTS CONVENTION - IDMA PAC 2003
    HIGHLIGHTING EUROPEAN PHARMACOPOEIA COMMISSION

    In line with the Pharmaceutical Analysts Conventions - IDMA PAC 97 to IDMA PAC 2002- held successfully so far, this year IDMA PAC 2003 was held on 19th & 20th September 2003 in Mumbai.

    The Convention was focused on the regulatory affairs related to registration in and export to Europe. Three full sessions were devoted to European Pharmacopoeia and one session covered issues relating to phamacopoeial applications in India. Top officials from European Pharmacopoeia Commission led by Commissions Director were participated in the Convention. The Convention was well attended by over 300 participants and over 50 invitees from the regulatory, academic and industrial fields.


    AMENDMENTS TO I.P.96 MONOGRAPHS

    The Technical Sub-committee of IDMA regularly submits suggestions for amendments to the I.P. 96 monographs to the D.C.G(I) for their incorporation in I.P.96. Government has so far issued eight lists of amendments to I.P. 96.


    IDMA-APA SEMINARS

    Seminars/Workshops are being organized on regular basis at various pharma growth centers in the country on topics of interest to the pharma analysts.


    ISSUES RELATING TO EXIM POLICY PROVISIONS, EXPORT PROMOTION & CUSTOMS

    Besides submitting suggestions for improvement/modification in the EXIM Policy, the Association regularly takes up with the authorities various strategic issues relating to the constraints faced by the member companies in implementation of the EXIM Policy provisions. The difficulties faced by the member companies at the Customs on operational side are also presented to the authorities. Association’s representatives on the Chief Commissioner of Custom’s Open House meeting also take-up operational issues for their necessary redresal.


    EXPORT DATA BANK

    The Association has collected data/reports on countries such as Canada, Turkey, South Africa, Chile, Mozambique, Belarus, Brazil, Tunisia, Maldives, Myanmar, Indonsia, Romania, Yerevan (Armenia), Argentina, Kuwait, Ethiopia, Syria, etc.

    The copies of these reports/dates would be made available to the member companies on request and written requisition.

    Pre-Budget and Post-Budget submissions on issues relating to direct (Income tax, corporate tax) and indirect taxes (Customs & Excise duties) are made to the authorities on regular basis.