"Proposed Drugs Law Overhaul Draws Industry Opposition Over Criminalisation and Consultation Gaps"
CDSCO
Central Drugs Standard Control Organisation; India's apex central drug regulator responsible for standards, approvals, and import regulation.
Spurious drug
A drug that is a counterfeit, substituted, or contains no active ingredient; distinct from substandard (below specification) drugs.
India's pharmaceutical and medical device sector is currently governed by the Drugs and Cosmetics Act, 1940 — a colonial-era legislation that has undergone numerous amendments but has never been comprehensively replaced. The Central Drugs Standard Control Organisation (CDSCO) functions as the apex central regulator, responsible for setting standards, approving new drugs, and regulating imports, while State Drug Controllers handle licensing, manufacturing inspections, and enforcement at the state level. This dual structure — central standard-setting paired with state-level enforcement — has long been identified as a source of regulatory gaps, particularly in detecting and acting against spurious and substandard medicines.
The medical device sector, though regulated under the same Act, has distinct scientific and engineering characteristics that pharmaceutical-centric regulation does not adequately address. Globally, regulators such as the US FDA and the European Union's Medical Device Regulation (EU MDR) treat devices as a separate regulatory category, requiring specialised frameworks covering biocompatibility, software lifecycle safety, and usability engineering. India's attempt to modernise its drug law has been in motion since at least 2022, when an earlier draft Bill was circulated but withdrawn following industry opposition — a pattern that appears to be repeating with the current draft.
The proposed Bill to replace the Drugs and Cosmetics Act, 1940 seeks to consolidate and update the regulatory framework for drugs, cosmetics, and medical devices. However, the draft has attracted criticism on several structural grounds. First, it continues to treat medical devices as an adjunct to pharmaceuticals, applying pharmaceutical terminology — such as spurious and misbranded — to devices where these concepts do not translate meaningfully. A wrong font size on a device label or a software version mismatch, for instance, would constitute misbranding under the draft, potentially attracting criminal penalties.
Second, the Bill significantly expands the powers of Drugs Inspectors, granting them authority to direct immediate cessation of operations and to arrest individuals on the reasonable belief that an offence is being committed or is about to be committed. …
Examine the structure of India's drug regulatory framework under the Drugs and Cosmetics Act, 1940, and assess the roles of CDSCO and State Drug Controllers in ensuring drug quality.
Critically evaluate whether India's current penal and administrative mechanisms under the Drugs and Cosmetics Act are adequate deterrents against the manufacture and distribution of spurious drugs, and suggest institutional reforms.
The Jan Vishwas (Amendment of Provisions) Act is best described as legislation that:
Consider the following statements regarding the proposed Bill to replace the Drugs and Cosmetics Act, 1940:
1.The Bill proposes to create a separate regulatory body with engineering experts specifically for the medical devices sector.
2.The Bill grants Drugs Inspectors the power to arrest individuals on reasonable belief that an offence is being committed.
3.The Bill's approach to criminalising minor technical lapses is consistent with the Jan Vishwas Act's regulatory philosophy.
Which of the statements given above is/are correct?
Which of the following global regulatory frameworks are cited by India's medical device industry as benchmarks that treat medical devices as a category distinct from pharmaceuticals?
1.EU Medical Device Regulation (EU MDR)
2.US FDA device framework
3.WHO Good Manufacturing Practices for Pharmaceuticals
Select the correct answer using the codes below:
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