‘‘India’’s pharma sector is currently undergoing unprecedented regulatory changes’’

The Indian regulations for pharmaceuticals are witnessing a transformation. There are several examples where small and big changes that have been proposed has the potential to impact the industry directly or indirectly. While any effective and meaningful measure to strengthen regulations should be considered positively by the industry, not all of such changes are being approached and implemented in a pragmatic and objective manner.

Till the end of 2011, the new drug/clinical trial (CT) approval process was based on the letters from experts and scrutiny by Central Drugs Standard Control Organisation (CDSCO) officials. In the year, 2011, CDSCO constituted 11 New Drug Advisory Committees (NDAC), on par with United States Food and Drugs Administration (US FDA) to oversee the CT/new drug approval process. While this action strengthened the review/approval process, it has also led to significant stretching of product approval timelines, and consequently the number of new drug approvals has gone down with the advent of NDACs. This is primarily because NDAC often requests clinical trials on simple combinations that have been in use for decades in the country, thus duplicating efforts and delaying the process. Hence, the patient access to these medical benefits has been delayed or unmet.

Since long, there has been introduction of newer fixed dosage combinations (FDCs) into the Indian pharma market, approved by state regulators based on therapeutic rationale, some of which were considered as irrational in view of them being not approved anywhere across the globe. On the other hand, in fact, such FDC’s in chronic care do improve patient compliance, and are widely prescribed by the ‘Registered Medical Practitioner’. The Drugs Controller General of India (DCGI) vide circular dated Jan 15, 2013 introduced a proposal giving a chance to the industry to prove the safety and efficacy of such FDCs, which don’t yet have DCGI approval. This corrective measure will ensure availability of safe and effective FDCs with DCGI approval. However, the pharma industry is still seeking more clarity on data requirements and regulatory framework to fulfil the above criteria. For FDCs which are already in market for many years and have a good therapeutic record, some flexibility in additional data requirement through clinical trials should be considered. This regulatory directive will have an impact on the medical community and patient convenience as many products will get discontinued for some time.

Many initiatives have been undertaken by the DCGI for ensuring close monitoring of clinical trials. Some of these steps include registration of ethical committees and filing of Informed Consent Form (ICF) under video recording. This is a welcome step but greater support is needed to implement these requirements.

India, like any other regulated country, is taking bold steps in banning of drugs in the interest of patient health and safety. Some of the recent examples include Nimesulide for under children of 12 years, formulations containing Phenylpropanolamine (PPA) and Sibutramine containing formulations. However, all above are based on the ban status in the innovator countries. It will be prudent to have our own database, specific to our own population that can form basis for proactive ban in India, obviating the need for dependency on international markets.

While many changes have been undertaken by the government, there are still some areas that need improvement. A classic example is implementation of real time stability testing conditions in the Indian sub-continent. On one hand, there are the WHO recommendations for temperature and humidity of 30oC and 70 per cent RH respectively. On the other hand, Schedule – Y of the Drugs and Cosmetics (D&C) Act that recommends data generation at 30oC and 65 per cent RH leads to subjectivity in implementation. Amendments are needed in the D&C Act to strengthen data requirements for grant of manufacturing licenses at State level for new drugs post four years after DCGI approval. Also, the assignment of shelf-life for pharma products needs to be delinked from shelf-life for API, and should be based on the stability data of the drug product.

India’s pharma sector is currently undergoing unprecedented regulatory changes. While majority of changes are directed to improve accessibility and affordability of safe and effective medicines for the Indian Population, the industry would expect greater collaboration from the government in implementing these changes with more clarity on data requirements and implementation time frames. Perhaps a constitution of government – industry partnership could be an optimum solution to serve our ultimate stakeholder, the patients.

– Arun Sawhney, Chief Executive Officer and Managing Director, Ranbaxy Laboratories