Study Points to Shortage of Inspectors, Complex Regulatory Framework in India

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 12-15-2015 15:35


The Associated Chambers of Commerce & Industry of India (ASSOCHAM) and the research firm, RNCOS, have issued a report highlighting a shortage of inspectors for the pharmaceutical industry in the country. According to the report, India has only 1,500 inspectors to inspect more than 10,000 plants engaged in pharmaceutical manufacturing.

"While at times, the US Food and Drug Administration (FDA) gets into minute details which have more to do with the cumbersome procedure rather than quality, we need to get our own house in order by way of continuous skilling of the regulators at the national and state levels in sync with the best global practices," said ASSOCHAM Secretary General D S Rawat in a statement.

The study points to what it terms a "mismatch" between the country's domestic regulatory mechanisms and the international position of Indian pharmaceutical exports, raising concerns that a lack of regulatory resources could lead to a setback in pharmaceutical expoerts, which were $14.8 billion in the fiscal year 2013-2014.

According to the study, India ranks fourth in pharmaceutical production in the world with a production output of about $31 Billion in 2014. The country has a 1.4% share by value and 10% by volume in the global pharmaceutical industry. The country's domestic pharmaceutical market was valued at $15.4 Billion in 2014, and is expected to expand at a compound annual growth rate of 13.3% to $32.7 Billion by 2020.

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 Central Drugs Standard Control Organization (CDSCO) with zonal offices and the state Food and Drug Administrations. "This makes the process of obtaining license, for pharmaceutical product manufacturing complex," says the study.

The study was critical of the regulatory framework in India. "There are numerous patent offices in metro cities all over India. Each of these offices follows non-uniform patent practices. Thus, these varied practices and poor centralized controls affect the quality of the pharmaceutical products. The pharmaceutical industry in India has a concurrent regulatory practice, which is sometimes poorly manned and poorly headed by less knowledgeable pharmacists who are not properly trained. Lower awareness among such personnel regarding the quality norms leads to non-uniform implementation of regulatory standards," It further said that "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. Manufacturers which are not present in these zones are not able to avail these benefits, which they can use for the implementation of quality standards in their manufacturing sites."

"With the absence of global harmonization of quality systems makes it all the more challenging for India that exports to US, Europe, Australia, Japan, etc, to comply with a plethora of regulatory guidelines across the globe, said Mr. Rawat.



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