Health ministry to amend Sch D-1, D-11 of D n C Rules regarding GMP certificate for import of drugs into India

Mumbai, November, 2016

The Union health ministry will soon amend Schedule D I and Schedule D II of the Drugs and Cosmetics Rules, 1945 regarding the GMP certification by the regulatory authority of the country of origin for import of drugs into India.

The import of drugs in the country is regulated under the D&C Rules through the system of registration and import licence. The manufacturers abroad who intend to export drugs to India are required to obtain registration certificates for facilitating the import of his products into India. For this purpose, the applicant is required to furnish information and undertaking as specified in Schedule D-1 and D-11 of the D&C Rules.

Specific clauses in the Schedules I read as, "2.3 A copy of Good Manufacturing Practice (GMP) certificate, as per WHO-GMP guidelines, or Certificate of Pharmaceutical Products (CPP), issued by the National Regulatory Authority of the foreign country concerned, in relation to the bulk drugs or formulations or special products, meant for import into India."

Clauses in the Schedules II read as, "1.4 GMP certificate in WHO formats or certificate of pharmaceutical products (CPP) issued by National Regulatory Authority of the country of origin (duly notarized)." WHO under its guidelines for good manufacturing practices in respect of pharmaceutical products moving in the international market has provided a WHO Certification Scheme for quality assurance. The models of the certificates required to be issued have beeh specified in the WHO Technical Reports Series 908. The Certificate of Pharmaceutical Products (CoPP) and WHO GMP Certificates are required to be issued by the National Regulatory Authority of the country.

But, it has been observed that many of the manufacturers abroad are unable to obtain WHO certificates as prescribed in the WHO guidelines, but these facilities have been inspected and internationally imports from such units has been permitted on the basis of the approval of these facilities by the ICH regulators.

European Countries as per European Directive 2011 /83/EC on the community code relating to medicinal product for human beings require Written Confirmation from the National Regulatory Authority of the country of origin for import. India is issuing such Written Confirmation to the manufacturers exporting their drugs to the countries under European Union.

So, the Schedule D I and Schedule D II of the Drugs and Cosmetics Rules, 1945 were therefore proposed to be amended to include the certificate of written confirmation for active substances for export to EU countries as well as certificate issued by USA, Japan, Australia, Canada or EU for the purpose of permitting import of drugs into their country.

According to sources, the Drugs Technical Advisory Board (DTAB) of the Union Health Ministry has also given its final nod for the proposed amendment.

Accordingly, the sub-clause 2.3 of Schedule D I is proposed to be amended as, "2.3. A copy of Good Manufacturing Practice (GMP) certificate as per WHO-GMP guidelines or Certificate of Pharmaceutical Products (CPP) or written confirmation for active substances exported to European Union equivalent to GMP certificate as per WHO - GMP guidelines, issued by the National Regulatory Authority of the country of origin or a copy of the certificate equivalent to GMP certificate as per WHO GMP guidelines issued by USA or Japan or Australia or Canada or European Union for the purpose of marketing of the drugs in their country, in relation to the bulk drugs or formulations or special products meant for import into India."

The sub-clause 1.4 of Schedule D II is also proposed to be amended as, "1.4 GMP certificate in WHO formats or Certificate of Pharmaceutical Products (CPP) or Written Confirmation for active substances exported to European Union equivalent to GMP certificate as per WHO - GMP guidelines, issued by the National Regulatory Authority of the country of origin or a copy of the certificate equivalent to GMP certificate as· per WHO GMP guidelines issued by USA or Japan or Australia or Canada or European Union for the purpose of marketing of the concerned drug in their country." Pharmabiz