Biologics Regulation in India - - BioPharm International


Biologics Regulation in India

BioPharm International
Volume 21, Issue 3


India has recently begun to tackle its red tape to accelerate drug development. To encourage would-be makers of biogenerics, for example, India's regulators have begun to issue guidelines on biosimilars and the requirements for obtaining approvals.5 In 2005, India's legislature enacted an amendment to the prevailing Drugs Control Act, modifying its rules on clinical trials. Previously, for example, Phase 3 trials in India of a drug intended for market in the country were allowed to proceed only if all prior studies had been completed in Western countries. This rule was relaxed to encourage the development of new drugs in India. Now, in contrast, only Indian companies are permitted to conduct first-in-human studies and involve substantial effort to gain approval.

India has also taken pains to streamline its clinical trials approval process. Ethics committee and DCGI reviews of applications now generally occur in parallel and take no more than 14 weeks.6 Occasionally, trial sponsors speed up this process further by submitting a draft application to the DCGI to get the clock ticking, and then file more complete data weeks later.7

The long-term goal is to encourage the industry by reducing turnaround times for all regulatory approvals. Recent recommendations included the following targets:8
  • approval of preclinical animal studies 45 days
  • approval of a human clinical trials protocol 45 days
  • examination of clinical trials and response 90 days
  • DCGI and GEAC approval decision (simultaneous) 45 days

Of course, fast approvals don't always make for good enforcement. In 2004, C. M. Gulhati, then the editor of India's Monthly Index of Medical Specialties, cited an example in which a voluminous protocol on trastuzumab [a biologic, a.k.a. Herceptin], sponsored by Roche, was approved within five working days. "It is humanly not possible to read and analyse the bulky documents in such a short period," Gulhati said.9


In the manufacturing area, though, the country has been tightening the rules and enforcement. An amendment to the regulations, "Schedule M" of the Drug and Cosmetics Act, now specifies the good manufacturing practice (GMP) requirements for factory premises and materials. These requirements were modeled after US FDA regulations, to improve regulatory coordination between Indian and US regulators. The change has not met with universal approval, however. Small-scale manufacturers in particular argue that although the new requirements will improve quality, the changes should have been phased in gradually. It took the FDA nearly 15 years to implement similar programs in the US, they argue.


In the wake of drug-trial scandals in the early 2000s, the Indian government acknowledged the need for tighter regulatory standards. Regulatory officials announced stricter enforcement to international good clinical practice (GCP) and World Health Organization protocols. The DCGI also announced that it would begin regular inspections of ongoing trials.10

More importantly, two major regulatory initiatives have been taken. The first is the creation of the National Biotechnology Regulatory Authority (NBRA), under the Department of Biotechnology (DBT), as part of India's long-term biotech sector development strategy. The creation of the NBRA is expected to be confirmed by the legislature this year and become fully operational by 2010.11,12 According to the DBT's latest development strategy, the NBRA will be an "independent, autonomous, and professionally led body to provide a single window mechanism for the biosafety clearance of genetically modified products and processes." In other words, the NBRA will replace many of the other bureaucracies with which biologics makers in India now must interact for biosafety issues. The NBRA reportedly will also include a training center for its biotech regulators, to build and maintain their professional competence.12,13

The second major initiative, for which enabling legislation is expected in 2008, will affect the entire Indian pharmaceutical industry. This is the replacement of most state, district, and central drug regulatory agencies with a single, central, FDA-style agency, the Central Drug Authority (CDA). Over a five-year transition period, this new agency will take on nearly all facility-inspection, manufacturing-license, and data-evaluation functions concerning drugs in India.

The CDA is expected to have separate, semi-autonomous departments for regulation, enforcement, legal, and consumer affairs; biotechnology products; pharmacovigilance and drugs safety; medical devices and diagnostics; imports; quality control; and traditional Indian medicines. It will set up offices throughout India and will be paid for by inspection, registration, and license fees. Its enforcement powers will be strengthened by a new law increasing the criminal penalties for illegal clinical trials.1,14,15

India has recognized the importance of these issues for some time, but it has taken the country several years to go from the talking stage to the implementation of solutions. Meanwhile, its sales of pharmaceutical products to the West have been growing and the risk of a major setback because of regulatory or quality problems has been rising. As it puts its own house in order, India has coordinated some of its regulatory functions with Western organizations. The US Pharmacopoeia established an office in Hyderabad in 2007 and has already been paid by at least one Indian drug maker, Dr. Reddy's Laboratories, to inspect its facilities.16 A representative of the Indian pharmaceutical lobby also recently has expressed openness to an expansion of the FDA's oversight of Indian manufacturing.4 As India expands its global drug and biologics production, US and Europe, as the world's largest drug importers, will likely expand their regulatory support in the development of the country's regulatory systems.

Eric Langer is president and managing partner at BioPlan Associates, Inc., Rockville, MD. He is also the editor of Advances in Biopharmaceutical Technology in India, 301.921.9074.

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