Eric Langer
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During the past decade, India has been actively reforming its key industrial sectors to compete at world-class levels. These
reforms have been motivated by its expanding global trade and a self-image that has moved beyond that of a developing country.
As with other industrializing countries undergoing rapid shifts, India clearly recognizes the need to restructure its regulatory
system so that its biopharmaceutical industry can compete in international markets.
India's regulatory situation is described in detail by Uri Reichmann, Bharat Kurana, and Steven Ferguson in the publication,
Advances in Biopharmaceutical Technology in India, a joint study by BioPlan Associates, Inc., and the Society for Industrial Microbiology. According to the authors, a new
regulatory structure in India is being formed, "to centralize drug approvals and tighten the still somewhat lax manufacturing
practices that have led to a proliferation of poor ethical practices and substandard drugs."1
THE CURRENT REGULATORY SYSTEM
India's federal regulatory structure has been plagued by some of the classic problems of developing countries, including red
tape and corruption. Expanding bureaucracies have been particularly hard on biologics manufacturers in India, who must seek
approval from multiple state, district, and federal agencies for routine activities such as the importation of recombinant
molecules and cell cultures for research purposes.2
In India, state authorities are responsible for licensing a drug maker's research and manufacturing facilities. But the federal
Central Drugs Standard Control Organization (CDSCO) and the drugs controller general of India (DCGI), have been responsible
for approvals of preclinical and clinical trials, new drug applications, and the importation of drugs from abroad. For biologics,
additional approvals have been required by other offices and agencies, including the Genetic Engineering Approval Council
(GEAC), Recombinant DNA Advisory Committee (RDAC), Review Committee on Genetic Manipulation (RCGM), Institutional Biosafety
Committees (IBSC), State Biosafety Coordination Committees (SBCC), and the District Level Committees (DLC).
Arguably, a worse problem has been the general lack of state-level regulation in certain areas. India's state drug regulatory
authorities (DRAs) often lack the staff to police their respective domains. These staffing problems, combined with their relatively
limited technical experience in regulatory issues, makes for a difficult situation. The DRAs have been susceptible to influence
by local political authorities, and in some cases have been able to do little to prevent illegal drug manufacturing and marketing
activities. Manufacturers that set up operation in states where regulatory oversight and enforcement are weakest can then
market their drugs in the rest of the country. One senior federal regulator in India lamented, "There are hardly any regulations
or control over the mistakes or offences committed by the State DRA Officers who permit even [the] manufacture [of] banned
or new [i.e., unapproved] drugs."3
India's relatively lax regulatory environment potentially affects every country that imports its drugs. Products made in India
accounted for 20% of US FDA generic applications in 2006, up from only 7% in 2001. This increase has required additional cooperation
between the US and Indian regulatory authorities. Although interactions between the FDA and Indian companies seldom make it
to the media, in 2006 Ranbaxy Laboratories and Wockhardt, two of the largest Indian drug makers, were sent warning letters
by the FDA over documentation and quality-control issues.4
