Govt tweaks certification norms to aid pharma trade
New Delhi: The government has decided to increase the validity of the World Health Organization’s (WHO) good manufacturing practices (GMP) certification to three years from the existing two years for companies exporting pharma products to other countries.
The move is expected to boost pharma exports and aims to promote ease of doing business.
The certificate of a pharmaceutical product (COPP) is issued under WHO GMP based on guidelines laid down by the health agency and is aimed at diminishing the risks inherent in pharmaceutical production. The certificate helps the regulator ensure that drugs are consistently produced and are quality controlled before they leave the country.
The Central Drugs Standard Control Organization (CDSCO), which is the national drugs regulatory authority, regulates the import and export of the drugs in the country, through the port offices located in different parts of the country.
The WHO GMP certificate is mandatory in most global markets for pharmaceutical companies to be able to sell medicines. The manufacturer of an exporting country must be licensed by the regulatory authority of that country and comply with the WHO GMP guidelines. The latest move by the government is, thus, set to reduce delays and boost ease of business.
“The move is aimed at reducing delay in the registration process and promoting exports,” S. Eswara Reddy, Drug Controller General of India (DCGI) said at the sidelines of international exhibition of pharma and healthcare (iPHEX) on Tuesday.
The international pharmaceutical industry is expected to grow at a compound annual growth rate (CAGR) of 22.4% to touch $55 billion by 2020, from $20 billion in 2015, according to the Pharmaceuticals Export Promotion Council of India.
India’s pharmaceutical space is dominated by generic drugs, which account for around 70% of the market. India’s pharma exports stood at $16.8 billion in 2016-17 and are expected to grow by 30% to reach $20 billion by 2020.
Federation of Pharma Entrepreneurs (FOPE) president B.R. Sikri called it an encouraging move. “It is great news for the pharma sector. Industry has been representing for the extension of period for many years now and finally Dr Reddy took the lead and succeeded in his mission.”
Earlier, the matter to extend the validity was also taken up by the Drug Consultative Committee (DCC), the drug advisory body, but the proposal was shot down.
While WHO does not specify the time period of validity of the COPP in its current guidelines, at present in India, the COPP is issued with the validity of two years which can be extended twice for six months each. The validity of the certification varies from country to country. Some countries like Korea issue COPP with the validity for three years. The COPP issued by EU countries have no mention of its validity. The US FDA issues the certificate with validity of two years.
“It would be appropriate to grant COPP for a period of three years with the condition to monitor the WHO GMP by inspection on a periodic interval. This would reduce the delay in grant of COPP by reducing the burden on state licensing authorities and would also facilitate exports from the country,” added Dr Reddy.
To further boost exports, commerce and industry minister Suresh Prabhu today asked pharma firms to increase R&D investments and develop new markets. “The government is taking steps to boost pharma exports such as seeking greater market access for India’s products in countries like China. Make more investments in R&D activities so that the pipeline (for new medicines) does not get dry,” he said, adding that research and development investments will domestic growth.
He also called for finding ways to make healthcare more affordable to people by reducing costs.