India tightens licensing and manufacturing standards for drug exports

Centre will take over drug certification and manufacturing licensing of drugs meant for exports from state authorities from October 1

The Drug Control General of India –country’s central drug authority — will become the authority to issue the WHO-mandated Certificate of Pharmaceutical Products (CoPP) and WHO Certification Scheme for Good Manufacturing Practices (GMP) for medicinal products, from October 1, 2009.

Copp and GMP certicates have been issued in India, currrently, by the state drug authorities.

The decision to take back the authority from the states was made during the 40th drug consultative committee meeting in June, after repeated concerns by WHO over quality of pharmaceutical products moving in international commerce, stated an official communique issued by the Central Drug Standards Control Oraganisation – DCGI’s office.

“The matter was discussed in the 40th meeting of DCC held at New delhi on 29-06-2009 and the States were informed that this activity would henceforth be taken over by CDSCO in a period of three months and WHO [was] informed accordingly,” the communique stated.

CDSCO will implement WHO certification scheme from 1st October 2009. The product licences or CoPPs will be issued by offices of CDSCO after its regulatory officials inpecting the manufacturing facilities of companies seeking licence.

The WHO certification scheme is an an administrative tool developed in response to the requests of WHO member states. It is a voluntary/non binding agreement to exchange information on the quality safety and efficacy imported drugs.

CoPPs are intended to give assurance to countries that are importing pharmaceutical products but have no national capacity to assess the safety, efficacy and quality of the drugs they import.

CoPPs enable importing countries to get all the information they need to know about the product they import.

CoPPs while providing information on the product, on GMP status of the manufacturing plant assures that the product information accompanying the certificate is the same as the one approved by the certifying country.

CoPPs also provides information about the certifying authority. It makes companies to apply GMP requirements similar to those recommended by WHO.

Centralisation of drug licesing and manufacturing can be viewed as latest in a series of effective initiatives taken by the CDSCO as part of its efforts to streamline and reform the entire drug regulatory machanism.

DCGIs office has recently set clear timeline for clearing and processing applications and issuance of certifications. Besides de-cluttering the licensing, registration processes CDSCO has also brought specific set of guideline for medical devices, for compulsory registration clinical trials etc.

CDSCO’s move to stremline export licesing and manufacturing also achieve significance at a time made-in-India generic drugs bear the brunt of quality in some destinations especially in the African continent.

Aspersions are also cast on India as possible hub of trade in counterfeit medications which is currently rampant in South Asian region.

CDSCOs efforts will help in a long way to tackle these notions, in this context, industry sources said.