The mismatch between India’s domestic regulatory system and international regulations is resulting in recalls and rejected drugs, leading to unrest and frustration
India has a meagre number of 1,500 well-equipped inspectors for more than 10,000 factories engaged in pharmaceutical products, leading to the country's products facing regulatory hurdles in overseas markets.
The Indian pharmaceutical sector, which has made rapid strides in global markets, is now faced with several regulatory hurdles, especially in the US and EU, reports a study titled Focus on Quality Management in Pharmaceutical Manufacturing, jointly conducted by The Associated Chambers of Commerce and Industry of India (ASSOCHAM) and RNCOS.
‘Although the US Food and Drug Administration (FDA) sometimes gets into minute details that have more to do with cumbersome procedures rather than quality, we need to get our own house in order to get our regulators at the national and state levels in sync with the best global practices. However much we may wish otherwise, the pharma sector is and will always will be one of the most regulated global industries,’ said ASSOCHAM Secretary General D S Rawat.
The mismatch between the domestic regulatory system and international regulations is resulting in recalls and rejected drugs, leading to unrest and frustration. According to the study, India ranks fourth in worldwide pharmaceutical production with a production output of about US$31bn (2014). The country has a 1.4% share by value and 10% by volume in the global pharma industry. The domestic market was valued at $15.4bn in 2014 and is expected to expand at a CAGR of 13.3% to $32.7bn by 2020. Driven by favourable demographics — including an aging population, increasing lifestyle diseases, steep growth in disposable incomes and the increasing penetration of Indian drug players in the global market — India is likely to be among the top three pharmaceutical markets by incremental growth and the sixth largest market globally in absolute size, noted the study.
Pharmaceutical manufacturing is managed by multiple regulatory authorities, which include the Central Regulatory Agency, the office of the DCGI (Drugs Controller General of India) under the Central Drugs Standard Control Organisation (CDSCO) and the FDA. This makes the process of obtaining a pharmaceutical product manufacturing license very complex. There are numerous patent offices all over India, each of which follows non-uniform patent practices. Thus, these varied practices and poor centralised controls affect the quality of pharmaceutical products.
The pharmaceutical industry in India has a concurrent regulatory practice, which is sometimes poorly staffed and headed by less knowledgeable pharmacists who are not properly trained. Low awareness among such personnel regarding quality requirements leads to the non-uniform implementation of regulatory standards. SMEs in the Indian pharmaceutical industry do not have the funds or the capacity to conduct quality checks. The government only provides subsidies to those pharmaceutical companies that are located in special economic zones. ‘In the absence of global quality harmonisation, it makes it all the more challenging for India to export to the US, Europe, Australia and Japan, etc., and comply with a plethora of diverse regulatory guidelines,’ said Mr Rawat.