Why India needs an overarching drug regulator like USFDA

The future of the Indian pharma industry lies in moving up the value chain and innovating in complex generics, speciality drugs, new biological entities and new chemical entities and the country needs to build regulatory expertise in these domains. Towards this, the CDSCO can have dedicated and specialised teams to provide in-house regulatory guidance to pharma innovators working on these innovative segments. Of course, creation of USFDA like regulatory body will prove to be a big boost to the Indian pharmaceutical industry

It is an undisputed fact that over the last more than four decades, the Indian pharmaceutical industry has registered an exponential growth, exporting affordable and quality medicines to more than 200 countries in the world, including the developed countries such as the US and the European nations. From a mere Rs10 crore in 1948 to more than Rs2 lakh crore at present, the Indian pharmaceutical industry has, indeed, come a long way to adorn the epithet of 'the pharmacy of the world'. For a sector which was dominated by the multinational drug companies until the 1970's, it is really a great achievement.

And the growth trajectory of the Indian pharmaceutical industry is still continuing as the Indian pharmaceutical industry is likely to reach $130 billion by 2030, growing at a CAGR of 12.3 per cent from $40.8 billion in 2020. The current market size of the pharmaceutical industry in India is estimated to be valued above $50 billion (2020-21) with a growth rate of 10-12 percent. The impressive growth is despite the Covid-19 pandemic and may be attributed to the industry's strong credentials in formulation development capabilities, trained workforce, and reputation in international markets such as the US and Europe. Surprisingly, the pharmaceutical industry in the country achieved the current global status without having an ideal policy and regulatory environment on account of the fact that the industry is being controlled by different ministries and agencies. While all the administrative and pricing related policies are regulated by the Ministry of Chemicals and Fertilizers, the issues related to quality of the drugs produced and marketed in the country are regulated by the Union Health Ministry. Policies related to investment and IPR as well as that of exports are regulated by the Ministry of Commerce and Industry. This multiple regulatory mechanism very often poses hurdles to the growth of these sectors to its full potential.

Of course, there is an urgent need to strengthen the regulatory framework in the country. The current Indian regulatory framework is traditionally geared towards safety and efficacy. However, it should also differentiate in favour of innovation. The Drug Controller General of India in the Central Drugs Standard Control Organisation (CDSCO) is the licensing authority, but there are multiple agencies with different mandates and expertise that a pharma innovator must navigate. Creation of a single overarching regulator like the US Food and Drug Administration (USFDA), the drug regulator having dedicated specialised teams to provide in-house regulatory guidance to pharma innovators and strengthening exchange of regulator best practices with international regulatory bodies could pave way for a conducive regulatory landscape to pave way for growth and innovation in the pharmaceutical sector in the country. At present, the regulatory approvals for innovative pharmaceutical products take about 18-24 months and from an industry viewpoint, the current regulatory structure appears complicated with a web of entities at the central and state levels having the responsibility of monitoring the sector. The Sugam portal, which is currently operational, has certain limitations such as there is no provision of adding multiple files greater than 10 MB and no automated document management workflows.

Under this background, a report released recently by FICCI and KPMG titled 'Impact of the pharma industry on the Indian economy in the post-Covid era', is of great significance. The report suggested that there should be a central overarching regulatory body such as the US FDA. A collaborative approach followed by different regulators will reduce overlaps and establish predictable timelines for requisite approvals. Faster approval and response time (bring down the current time taken for regulatory approvals for innovative products by at least 50 per cent); a single end-to-end digital platform connecting different departments/regulators and offering a single interface between a pharma innovator and regulator ; automated transfer of data across multiple departments and agencies for facilitating clearance by reducing time and efforts; building regulatory expertise in emerging areas such as NCEs, NBEs, biosimilars etc. to build a strong reputation of the quality of Indian products in the international markets; and collaborations with relevant international regulatory agencies to build expertise of Indian regulators on new drug approvals are some of the other suggestions in the report.

The future of the Indian pharma industry lies in moving up the value chain and innovating in complex generics, speciality drugs, new biological entities and new chemical entities and the country needs to build regulatory expertise in these domains. Towards this, the CDSCO can have dedicated and specialised teams to provide in-house regulatory guidance to pharma innovators working on these innovative segments. Of course, creation of US FDA like regulatory body will prove to be a big boost to the Indian pharmaceutical industry.

(The author is freelance journalist with varied experience in different fields)