The pharmaceutical industry in the country has sought Union health minister JP Nadda's intervention to extend the validity of Certificate of Pharmaceutical Products (CoPP) from the present two years to five years as the short duration of CoPP validity of two years is adversely impacting the pharma exporters in the country.
According to the industry, every Indian manufacturer requires grant of WHO GMP (CoPP) registration in order to export their products to different countries in the world. Currently, the CoPP is granted by the state licensing authorities (SLAs) after a joint inspections of the manufacturing facilities by the CDSCO (DCGI office) and state drug control department.
The validity of this CoPP at present is two years. For renewing the CoPP after the two years, the drug authorities have to make a re-inspection of the manufacturing facilities. But the problem is that more often the re-inspection is not possible in time due to various constraints such as limited number of regulatory staff available with the drug authorities.
Besides, regulatory authorities in most countries do not accept CoPP with remaining validity of only 6 months. This means that CoPP is effectively valid for only 18 months. An extension of six months is given by the authorities, but only after the completion of two years validity which is of no significant value as the registration process gets held up, according to the industry.
The product registration offered by all countries is valid for five years and the drug manufacturing license in India is also for five years. So, the validity of CoPP should also be five years, with a provision for inspection annually after two years, if required, as this will help to expedite the registration of products and in-turn will help boost the nation's pharmaceutical exports, the industry said.
CoPP is a basic document required by the exporters to export their products to the countries where there is no regulatory system of their own. The importing countries accept the CoPP as the proof of quality of the product. CoPP is issued by the SLAs for individual products. While the US, European Union countries, Canada, Australia and other developed countries have their own regulatory system and they import the drugs from the plants inspected and approved by their own agencies like the US FDA, countries in Latin America, Africa, CIS countries and other developing countries accept CoPP as the proof of quality of the product.