India has a meagre 1,500 well equipped inspectors for more than 10,000 factories engaged in pharmaceutical products leading to country's products facing regulatory hurdles in the overseas markets like the US which follow stringent protocols for the manufacturing processes, a sectoral study done by Assocham and research firm RNCOS has pointed.
"While at times, the US Food and Drug Administration (FDA) gets into minute details which have more to do with cumbersome procedure rather than quality, we need to get our own house in order by way of continuous skilling of regulators at national and state levels in sync with the best global practices. However much we may wish otherwise, pharma sector is and will always remain one of the most regulated sectors all across the world for the sake of public health," Assocham secretary general D S Rawat said releasing the study.
The mismatch between the domestic regulatory mechanism and the international regime is resulting in recall and rejection of drugs made by even some of the well-known companies, leading to unrest and frustration. In the long run, the pharmaceutical exports during the fiscal year 2013-14 reported $ 14.8 billion of drug exports would take a setback.
According to the study, India ranks 4th in pharmaceutical production in the world with a production output of about $ 31 billion in 2014. The country has a 1.4 per cent share by value and 10 per cent by volume in the global pharma industry.
The domestic pharmaceutical market was valued at $ 15.4 billion in 2014, and is expected to expand at a CAGR of 13.3 per cent to $ 32.7 billion by 2020.
India is likely to be among the top three pharmaceutical markets by incremental growth and sixth largest market globally in absolute size.
The pharmaceutical manufacturing is managed by multiple regulatory authorities; Central Regulatory Agency, the office of the DCGI (Drugs Controller General of India) under Central Drugs Standard Control Organization (CDSCO) with zonal offices and the State FDAs. This makes the process of obtaining license, for pharmaceutical product manufacturing complex.
The pharmaceutical industry in India has a concurrent regulatory practice, which is sometimes poorly manned by less knowledgeable pharmacists who are not properly trained.
Small and medium size manufacturers in the Indian pharmaceutical industry do not have the funds and the capacity to carry out the quality checks. The government provides subsidies to only those pharmaceutical companies, which are present in special economic zones.
BW Reporters
Haider Ali Khan is an alumnus of IIMC. He holds a degree in English Journalism from the prestigious campus. His passion includes Aviation, Technology, Politics and Sports.
