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Hailing the CDSCO for its efforts to implement the Revised Schedule M for bettering the quality of pharmaceutical products in India, the former director of the Tamil Nadu drugs control administration (TN DCA) M Rajendran has commented that the central regulator should apprise the Union health ministry about the need of strengthening the production of active pharmaceutical ingredients (APIs) in the country.
He said, 35 years ago India was self-reliant in manufacturer of APIs, the GATT Agreement and the low-priced APIs from China led to the closure of the API units in India. He said the present DCGI is aware of the history of the Indian pharmaceutical sector, so he should take the initiative to support the pharma industries to start API productions further. According to him, India continues to be import-dependent on China in the case of active pharmaceutical ingredients, it has to be stopped and the country has to become self-reliant.
Rajendran says that the CDSCO and the government should try to find out the reason for the decline in the production of raw materials in India. It is not only the replacement of GATT by the World Trade Organisation (WTO) in 1995, but the Indian pharma industry’s apathy in manufacturing APIs here. He said China is not bothered about GATT or WTO or any patent right. The government and the industry should have the intention to strengthen the API production to reduce the dependence on China. The Government of India should provide all kinds of support to revive those industries which were engaged in the production of raw materials.
He said if the industry’s requirements are fulfilled India can become the number-one manufacturer of APIs in the world. The APIs or the bulk drugs are the core of the pharmaceutical industry. They are the basic essential chemical compounds used in the production of any finished formulation drug product. But today, India is producing only 20% of the raw materials required for the manufacturing purpose in the country. It imports nearly 80% of the total requirement.
“The Indian pharma sector has grown up much in the last three decades. But even after 30 years’ growth, nobody, whether it is the government or the industry or the central regulatory agency, is taking any initiative to increase the raw material production. Everybody should understand one fact that this is the time to wake up, to increase the production of raw materials in India. They should try to find out the hurdles and resolve them. India needs a robust raw material manufacturing sector like that of formulations. He said there are some foreign countries who do not want India to become a pioneer in API production and formulations. But the government should understand the facts and act accordingly. The DCGI can provide suggestions to the government and advise the industry in the country to take up the production of APIs by establishing separate units. He should give all support to the people who come forward to start the units”, said Rajendran.
When asked about the hurdles for the industry to revive API production, the former state regulator said patent right is the major hurdle and everybody is afraid of it. He said although the GATT Agreement is there, China is manufacturing APIs and they are not considering it as a hurdle. Even if it is a hurdle, the government should try to resolve it or find a way out for the industries to manufacture the raw materials. He said several molecules were invented in India, but were taken away by other countries. Patent right is not a hurdle for producing APIs.
When he was informed of the recent growth in API productions in India, he said there is a report that the country is slowly improving in the field, but the speed is not sufficient when compared to the requirement. In the last two years the country started to produce about 38 kinds of raw materials which were in the imported list previously. Rajendran opines that the pharma industry should be given all legal and infrastructural support to manufacture as many APIs as possible in the country.
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