‘We’ve To Be Ready For Scrutiny’
When questions were raised on the quality of ‘Made In India’ drugs, the Central Drugs Standard Control Organisation (CDSCO) took it upon itself to help drug makers adopt international good manufacturing practices. The head of the apex drug regulation body, Drug Controller General of India G.N. Singh’s mandate is to safeguard the quality of the more than Rs 2 lakh crore worth of medicines and vaccines that India’s pharmaceutical industry produces. He inspects and regulates over 7,000 drug manufacturing companies in India. These companies are both domestic suppliers and exporters of bulk drugs and pharmaceuticals to more than 200 countries.
Singh tells Himani Chandna he is ready to take on even more. He has, in fact, asked the industry how his agency can reduce the regulatory burden to make it easier to do business in India.
Edited excerpts.
Recently, the US Food and Drug Administration cited violation of good manufacturing norms by Ipca Laboratories in India. Import alerts and ban on Indian pharma companies have become commonplace. Is there a reason to worry?
If we want to export drugs to global markets, especially to the US, we have to be ready for such scrutiny. This does not mean our products are not up to the mark. It just means they have different standards.
What are you doing to match the expectations of global regulators?
We are doing continuous risk-based assessment. We are inspecting and auditing drug makers to see if they are complying with the requirements. We are engaging more with global health watchdogs to understand their check list, and working with the industry to adapt those standards. The regulators from BRICS nation are meeting on 13 an 14 July to discuss their needs.
What kind of assistance can companies expect from you, if they want to change their business model from vanilla generics to complex generics?
We are hastening the approval processes for anti-cancer drugs and drugs for tuberculosis. Moreover, we are studying the national disease pattern and occurrence of rare diseases in India. We may also relax approval norms for new drug applications for kala-azar and filariasis.
How do you plan to tackle the quality concerns raised by international regulators?
State drug regulators are offering hand-holding to drug makers — larger multinationals to small and medium enterprises. Drug makers will be attaining a certificate by the end of 2018 from the Skill Development Council of India, which would train each and every employee of the firms.
The idea is to make drug makers understand the meaning of terms like good manufacturing practices for every employee at the organisation. The first step will be soft, careful hand-holding. Later, we will introduce penalties and revoking of licences.
In the domestic market, the prevalence of not-of-standard-quality (NSQ) medicines at retail outlets is 3.16 per cent. How do you plan to improve the quality of our medicines further?
Our objective is to bring the number to zero. However, it is almost an impossible task. Over the next two to three years, our goal is to peg down NSQ medicines to just two per cent of our total production.
