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THE PHARMA REVIEW (MAY - JUNE 2012)

Indian Regulatory Scene - A Pragmatic Approach

Kapil Bhargava1, M. Mitra2

Abstract: Technical regulations are efficient or effective only if they are understood, complied with or are effectively enforced. On the contrary, technical regulations which are not designed well to achieve their intended objectives, may contribute to inefficient regulatory arrangements. Further to this, inappropriately or non-uniformly implemented, technical regulations may lead to unnecessary restrictions on industry and trade leading to increase in costs of medicine, the patient pays. In India, Drugs & Cosmetics Act 1940 and its Rules are principle legislation for various activities related to medicine, cosmetics and medical devices production, import, new drugs permission and various modes of distribution. This Act along with its rules & directives issued by the courts from time to time in various cases are binding legislation. In addition to this, India also has “soft-laws” too. E.g. Drugs Consultative Committee (DCC) recommendations, the guidelines issued by the Drugs Controller General (I) and in few cases guidelines issued by WHO & ICH, which are not legal binding. Having two pieces of law parallel in operation, the challenge is to develop a regulatory system which can effectively ensure that regulatory compliances are optimised. Ensuring compliance by regulators is a bureaucratic exercise, however the key words for functioning are Clarity, Effectiveness, Transparency and Efficiency.
 
Clarity
Regulatory requirements and processes should be easily understandable and as accessible as practicable. These should make things as simple as possible, but not simpler, in achieving the regulatory objective. E.g. in above mentioned Act one of the definitions of “drug” includes — (iii) all substances intended for use as components of a drug including empty gelatine capsules. This amendment was incorporated principally to regulate the quality of hard gelatine capsules. Lack of clarity in the meaning of this provision as such, led regulators to understand meaning of “component” their own way more while controlling imports and at times controlling manufacture e.g. most excepients which do not require import license; under the guise of this part of definition discretion was available to officers to interpret the meaning and exercise control accordingly. Chemicals, buffers etc. in “in-vitro diagnostic kits’ too are treated as “components” and are covered under provisions. Citric Acid imports is a classic case which led to administrative penalty for few custom officers at Mumbai ports recently. This was mainly because of lack of clarity of the provision even in the minds of officials occupying high positions. A remedy could be that clarity of this phrase is to be explained in the regulation itself.

 

 

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