Centralized drug licensing in jeopardy as Indian court stays DCGI’s order

A regional Indian High Court has issued an injunction staying an order that aimed to restrict issuance of product manufacturing licences by state drug agencies, throwing a spanner on the central drug authority’s efforts to streamline the licensing practices to ensure quality of drug products manufactured across the country.

In an order issued in September, Drug Control General of India (DCGI) had directed all the zonal and sub-zonal offices of his Central Drugs Standards Control Organization (CDSCO) office to issue WHO-GMP Certificate of Pharmaceutical Products (CoPP) from October 1 this year.

The interim injunction staying the DCGI’s directive was issued by Madras High Court in the southern state of Tamil Nadu.

The High Court has asked to withhold the directive till further orders.

Certificate of Pharmaceutical Product (CoPP) and GMP certificates have been issued in India, currently, by the state drug authorities.

DCGI took the decision to take back the authority from the states during the 40th drug consultative committee meeting in June, after repeated concerns by WHO over quality of pharmaceutical products moving in international commerce.

According to the guidelines issued by Drug Controller General India’s (DCGI) office, 12 other officers including all heads of zonal and sub-zonal offices under CDSCO will also be responsible for issuing CoPP,apart from CDSCO.

CDSCO had notified earlier in September to all state drug authorities that DCGI would  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.

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.

Basically, through CoPPs WHO 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.

Importing countries get all the information they need to know about the product they import through CoPPs.

Besides providing information on the drug product, GMP status of the manufacturing plant CoPPs assure 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.

However, CDSCO effort to take back the authority of licensing did not seem to have gone down well with some of the state regulatory agencies as well as a section of domestic pharmaceutical industry, especially those who belong to small and medium segments.