1.
Reforms in India's Drug Import Regulations
Prelims:
Science & Technology, Governance
Mains:
GS Paper II-Government Policies and Interventions,
GS Paper III-Science & Technology
Current relevance:
The Union Health Ministry has proposed amendments to
the Drugs Rules, 1945 to simplify the import procedure for small
quantities of drugs used for examination, testing, and analysis.
Highlights:
1.
Regulatory Reforms in Drug Imports:
(i)
Introduces an acknowledgement-based system for
importing small quantities of drugs.
(ii)
Applicants can import eligible drugs after submitting a prior
intimation form, without obtaining a separate import licence.
2.
Scope of the New regulation:
(i)
Applicable to analytical and non-clinical testing of
imported drugs.
(ii)
Intended to facilitate research, product
evaluation, and quality testing.
3.
Exempted Drug
Categories
The simplified
procedure does not apply to:
(i)
Sex hormones
(ii)
Cytotoxic drugs
(iii)
Beta-lactam drugs
(iv)
Biologics containing live microorganisms
(v)
Narcotic and psychotropic substances
4.
Revised Shelf-Life Requirement:
Proposes
replacing the existing requirement of more than 60% residual shelf life with
a minimum residual shelf life of 12 months at the time of import.
Source: THE HINDU
- https://www.thehindu.com/news/national/government-proposes-simplifying-procedure-for-import-of-drugs-for-examination-test-or-analysis-under-drugs-rules-1945/article71150769.ece