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VOL. 12, ISSUE 2 (2026)
Applying of the Manufacture, Storage and Import of Hazardous Chemicals Rules for the pharmaceutical industry in India with reference to the US-FDA and other regulations – A review
Authors
Yudhistra kumar A
Abstract
In the globalized world, innovation of the new
drugs has resulted in the increase in the operational facility of the
pharmaceutical industry, further the existing and new industries, which are
expected to reach $130 billion by 2030, as India is eyeing to become third largest
economy in the world under the present leadership of Mr. Narendar Modi, prime
minister of India. India produces 60 % of generic drugs, which is the highest
in the world. India follows strict guidelines for complying with the legal
requirement for manufacturing, storage and importing of the chemicals, which
are required for the manufacturing of the consented drugs. In this regard on 27th November 1989 the ministry of environment and forest
has enacted the manufacturing, storage, import of hazardous chemicals (MSIHC)
rules 1989, which was amended in the year of 2020. Initially there were sixteen
rules and eight schedules but due to its amendment it has become to 20 rules
and 12 schedules. All these rules and the schedules are applied to the
pharmaceutical industry in India. These rules, which covers the procedure for
getting the approval of the site, getting the authorization for the operational
facility of the pharmaceutical industry, various hazards identification and its
mitigation, submission of the safety reports to the concerned authority,
various was of reporting the major accidents, handling of the onsite and
off-site emergency in the pharmaceutical industry. An overview of the
schedules, which are applied to the various MSIHC rules, has been covered in
this review. The application of the MSIHC rules were correlated with the US-FDA
current good manufacturing practices (CGMP) and its importance has been
stressed. Further we have also correlated with the other regulations such as
the toxic substances control act (TSCA) 1976 for the importing of hazardous
chemicals into the USA. All these acts, rules, and regulations, which are
having stringent standards for controlling the activities of the drug
manufacturing facility to achieve highest quality and safe handling of
chemicals during the manufacturing of the consented drugs.
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Pages:386-398
How to cite this article:
Yudhistra kumar A "Applying of the Manufacture, Storage and Import of Hazardous Chemicals Rules for the pharmaceutical industry in India with reference to the US-FDA and other regulations – A review". International Journal of Law, Vol 12, Issue 2, 2026, Pages 386-398
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