DCGI’s drug licence centralizing plan suffers another blow as Karnataka High Court stays order

DCGI’s directive to issue CoPP only through CDSCO has already been stayed by 2 high court orders

Drug Controller General India’s (DCGI) directive to centralize issuance of drug licensing process has suffered yet another set back as the High Court of Karnataka suspending the order for a period of 4 weeks.

The Karnataka High Court’s stay order comes as the third in succession against DCGI’s efforts to streamline drug product manufacturing certification procedure currently assigned with state drug administrations.

India’s drug regulator DCGI’s order assigning zonal offices of his Central Drugs Standards and Control Organization (CDSCO) to issue WHO-GMP Certificate of Pharmaceutical Products (CoPP) from October 1, 2009 has already received two interim stay orders from the High Court of Chennai.

The Madras High Court first stayed the DCGI directive last week acting on a petition filed by the Tamil Nadu Drug Inspectors Association.

The Madras high Court again issued another stay order after two days following a petition filed by the Federation of South Indian Pharmaceutical Manufacturers Association against DCGI.

Meanwhile, Dr Surinder Singh, DCGI has said that the centralisation of issuing of Certificate of Pharmaceutical Products (CoPP) was introduced in the country  to uphold the image of the country on the regulatory frameworks and to boost India’s fast-growing pharmaceutical exports to overseas.

India’s drug regulatory mechanism’s uniformity was questioned due to the multiple authorities in issuing the CoPP which is an important document for international commerce.

The drug regulator of the country is responsible to provide the latest data on CoPP to the visiting international regulators. In the present system, it is very difficult to compile the data of CoPP products in India. If CoPP is issued by my office only, it will be able to collect the data at a very short notice, the DCGI was quoted as saying in reports.

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.