The need for strengthening the central drug regulatory agency and a new drug regulatory framework was envisaged. This included quality control and GMP, registration and quality control of drugs both herbal and OTCs, approval of new drugs, continuing education of regulatory staff, creating infrastructure, and uniform standards of regulatory systems throughout the country. The report recommended full-time experts for the timely evaluation of dossiers submitted by the industry.
Today, after a decade, the promised reforms have not yet fructified. The regulatory infrastructure is creaking under undermanned and undertrained manpower, the lack of efficient IT systems, secure storage and filing systems, and the lack of uniform standards across the nation. The regulation for new drugs does not have full-time experts and committee meetings are often delayed by time constraints of the members who usually serve on academic or research institutions. In contrast to the 28-day timeline in the US, Europe and Canada, in India the timeline is vague and usually takes 6-8 months.
It is well known that a slow regulatory timeline and bottlenecks hamper a country from becoming an innovation-led economy. Take the example of European regulators, who have used a common sense approach to regulation. In the field of orthopaedic surgery, every new invention or device has come from Europe. German engineering has resulted in new innovations in optics and imaging. European surgeons are the first to adapt new technology and use it for the benefit of patients. Surgeons from North America and Japan, with slower regulatory timelines, come to Europe to learn from their counterparts about using new techniques. Thousands of skilled jobs have been created to manufacture these innovative products.
India could also be transformed into a knowledge power. For this, it needs to strengthen its own regulatory system, invest in hiring full-time staff for approving new drugs and clinical trials, training its staff, investing in digitising records, meeting regularly and giving timely approvals. New policies must be framed and implemented quickly.
The approval of a pharmaceutical drug takes extremely long. This is an inherently risky research endeavour, where only 1 in a 100 products make it into the market. It costs more than a million dollars to fill in the requirements of a Phase 1 schedule Y in India. If industry is to invest in finding new and affordable drugs for people of India, it needs a timely and transparent guideline for approval so scientific personnel can focus on a fixed goal post. Vague processes, unclear guidelines and variable timelines make the struggle longer and harder and many give up just to copy a known process so its easier for everyone. The regulatory system of the past heavily depended on just that premise: making generic copies, cheaper and faster. And approvals came on the back of the dossiers approved by other regulators. In fact, it was thought (erroneously) that biological drugs were exactly like chemicals and that generic copies had the same characteristics as the original. It was not to be. Complex proteins did not behave like easy-to-copy chemicals. Their incorrect manufacturing could lead to protein impurities, which would harm patients.
There is a lack of knowledge of new innovations or cutting edge science in our regulatory personnel. The science has changed, but the laws have not kept pace.
An innovation-led economy or knowledge superpower cannot depend on that alone. If we are to find new drugs for diabetes, which affects 50 million people in India, the clinical work must be done here with our own peculiar food effects and our own genetic make-up. If a new virus subtype exists in India or a type of resistant disease, answers must come from our own scientists.
If the drug regulator is to do its job, it must not be constrained by the lack of full-time personnel, equipment or training. It is fortunate that a pool of Indian origin scientists populate the worlds leading regulators like USFDA and UKMHRA. These scientists must be attracted back to India much as the Chinese have done to create a world class regulatory system. The Reserve Bank of India is an example of a mature regulator that frequently sends its staff to be trained by the World Bank, and often people who have international experience return to India to serve their country to regulate an increasingly borderless economic world.
Similarly, India must take its rightful place at the head table of global pharmaceutical companies devoted to high science and finding affordable drugs not just for India but also the world. We must believe we are leaders and not just followers and that our technology will soon be used by patients worldwide to positively impact heath and well being.
The author is director, Piramal Healthcare. She serves on the Scientific Advisory Committee and Council of Trade and Industry of the Prime Minister of India. She serves on the Deans board of Harvard School of Public Health and the Harvard Business School. She was a member of the Mashelkar Committee to Transforming India into a Knowledge Power in 1999