Jan Vishwas 2.0: What the New Decriminalisation Law Means for the Pharma Industry

Every few years, a law comes along that does not change what companies must do, but changes what happens to them if they get it wrong. The Jan Vishwas (Amendment of Provisions) Act, 2026 is one of those laws. For pharma, pharmacy and clinical establishment compliance teams, it is worth understanding closely, because it touches four laws you likely deal with every week.

Entry in Schedule	Act	Year	Sector
8	The Drugs and Cosmetics Act	1940	Drug/cosmetic manufacture, sale, licensing
9	The Pharmacy Act	1948	Registration and conduct of pharmacists
73	National Commission for Allied and Healthcare Professions Act	2021	Regulating allied health professionals (physiotherapists, technicians, etc.)
67	The Clinical Establishments (Registration and Regulation) Act	2010	Registration of hospitals/clinics

What Was the Compliance Regime Before Jan Vishwas 2.0?

Before this amendment, a large number of routine, technical or first-time lapses under these laws could still attract criminal prosecution. A cosmetics labelling error, a pharmacist who forgot to surrender a cancelled registration, a clinical establishment that missed a registration renewal, all of these sat in the same criminal framework as more serious drug-quality violations. That meant a magistrate’s court, a criminal complaint, and in some cases the possibility of imprisonment, even for lapses that had nothing to do with patient harm. This is not a new problem. Anyone who has represented a pharma company in a lower court for a purely procedural default knows how disproportionate this used to feel. The offence and the punishment were often mismatched, and the process itself, not just the outcome, was the real cost to the business.

What Has Changed Under the Jan Vishwas 2.0 Amendment?

The President gave assent to the Act on April 7, 2026, and it was published in the Official Gazette on April 8, 2026. It builds on the original Jan Vishwas Act of 2023 and carries forward the same idea: decriminalise and rationalise offences across central laws so that minor or technical lapses are handled through monetary penalties rather than criminal prosecution. In total, the Act decriminalises 717 minor offences and amends 784 provisions across 79 Central Acts. Three changes run through almost every entry in the Schedule, and they are worth remembering because they apply well beyond pharma:

1. Imprisonment is removed for many minor or technical lapses, leaving only a monetary consequence.
2. “Fine” is replaced by “penalty.” A fine is a criminal-court punishment. A penalty is an administrative or civil consequence. This shifts adjudication from a magistrate to a departmental adjudicating officer, with an internal appeal mechanism built in.
3. Cross-references are updated. Old references to the Indian Penal Code and the Code of Criminal Procedure are replaced with references to the Bharatiya Nyaya Sanhita, 2023 and the Bharatiya Nagarik Suraksha Sanhita, 2023.

There is also a built-in escalator under Section 3 of the Act. Fines and penalties across all scheduled enactments will automatically rise by 10% of the minimum prescribed amount every three years, unless the specific law already has its own revision mechanism. This is not a one-time correction. It is a standing feature of the law going forward. Here is what changed, provision by provision, in each of the four healthcare laws.

1. The Drugs and Cosmetics Act, 1940

This is the most heavily amended healthcare law in the Schedule, with 11 separate changes. Cosmetics-related offences are fully decriminalised and moved to a departmental penalty track. The more serious drug-quality offences under section 33-I retain imprisonment, but the penalty amounts attached to them go up substantially. The Ministry of Health and Family Welfare notified June 30, 2027 as the date these provisions come into force, through a notification dated June 22, 2026.

Section	Original Clause	New Clause	What Exactly Changed
27A(ii) Penalty for manufacture, sale, etc., of cosmetics in contravention of the Chapter	Punishable with imprisonment up to 1 year or fine up to ₹20,000, or both, for cosmetics-related contraventions	Liable to a penalty of ₹1 lakh or 3× the value of the confiscated cosmetics, whichever is higher	Imprisonment removed entirely; converted to a civil monetary penalty, and the amount is sharply raised and tied to the value of goods seized
28A Penalty for not keeping documents, etc., and for non-disclosure of information	Punishable with imprisonment up to 1 year or fine not less than ₹20,000, or both	Liable to penalty not less than ₹3 lakh, extendable to ₹5 lakh	Decriminalised; penalty floor raised roughly 15x
29 Penalty for use of Government Analyst’s report for advertising	Existed as a standalone offence provision	Omitted entirely	The offence is removed from the Act
30(1A) & 30(2) Penalty for subsequent offences	Existed as offence/penalty sub-clauses	Omitted	Corresponding offences dropped
New Section 30A	Did not exist	Creates an Adjudicating Officer (not below rank of Deputy/Assistant Drugs Controller) to hold inquiries and impose penalties, with a right of appeal within 30 days to a higher-ranked officer, and appeal disposal within 60 days	Establishes the entire administrative-adjudication machinery that replaces court prosecution for these offences
32B(1)	Referred to “clause (ii) of section 27A, section 28 and section 28A”	Now refers only to “section 28”	Narrows the scope of a cross-reference consequential to the decriminalisation of 27A(ii) and 28A
33(2) Compounding of offences	No adjudication/appeal rule-making power	Clauses (oa) and (ob) inserted, empowering rules on inquiry procedure and appeal format under new section 30A	Enables subordinate legislation to operationalise the new penalty regime
33-I(2) Penalty for manufacture, sale, etc., of Ayurvedic, Siddha or Unani drug in contravention of this Chapter	Contravention of Chapter provisions (except s.24) punishable with imprisonment up to 6 months and fine not less than ₹10,000; s.24 contravention punishable with fine not less than ₹10,000	Restructured: imprisonment up to 6 months and fine not less than ₹10,000 retained for general contraventions; s.24 contravention fine raised to not less than ₹30,000	Retains imprisonment here (unlike 27A/28A) but triples the minimum fine for one category
33J(c) Penalty for subsequent offences	Repeat offenders under 33-I(2)(a): imprisonment up to 1 year plus fine not less than ₹20,000 or 3× value of drugs, whichever higher; 33-I(2)(b) repeat offenders not separately specified	Unchanged wording retained for (a)-category repeat offenders; new clause for (b)-category repeat offenders: fine not less than ₹50,000 or 6× the value of drugs confiscated, whichever is higher	Adds an explicit, steeper repeat-offence penalty for the second offence category
36AB(1) Special Courts	Referenced “section 28A”	Reference to “section 28A” removed	Consequential clean-up following omission of the 28A imprisonment offence
36AC(1) Offences to be cognizable and non-bailable in certain cases	Referenced “section 28A” (twice); referenced “sub-sections (1) and (2) of section 30”	“Section 28A” reference removed; now refers only to “sub-section (1) of section 30”	Consequential clean-up matching the omission of sections 28A, 29, and 30(1A)/(2)

2. The Pharmacy Act, 1948

This is a narrower but still meaningful set of changes. The Act’s only real offence provision, failure to surrender a cancelled registration, is decriminalised and modernised, with realistic penalty amounts and a structured payment and default mechanism replacing what was a nominal, colonial-era fine.

Section	Original Clause	New Clause	What Exactly Changed
26A(4) Inspection	Cross-referred to “section 21 of the Indian Penal Code (45 of 1860)”	Cross-refers to “clause (28) of section 2 of the Bharatiya Nyaya Sanhita, 2023 (45 of 2023)”	Updates the reference from IPC to BNS, with no substantive change in meaning.
43(1) Failure to surrender certificate of registration	Punishable with fine which may extend to ₹50	Liable to penalty which may extend to ₹5,000	Decriminalised (from fine to penalty), and the maximum amount increased 100-fold.
43(2)–(3) Failure to surrender certificate of registration	Old sub-section (2) existed in a different form.	Substituted: penalty must be paid within 10 days of the person’s name being removed from the register; failure to pay and surrender the registration certificate attracts a further penalty of ₹1,000 per day of continuing contravention.	Introduces a clear payment timeline and a daily continuing-penalty mechanism, tightening enforcement.
43A(1) Adjudication of penalties	Referred only to “section 26A”	Now refers to “sections 26A and 43”	Widens the scope of the enforcement provision to also cover section 43.

3. National Commission for Allied and Healthcare Professions Act, 2021

This Act regulates allied health professionals such as physiotherapists and technicians through State Councils. The change here follows the same pattern seen across the Schedule: the existing fine for failing to surrender a registration certificate is converted into a penalty, and a full departmental adjudication and appeal mechanism is created where none existed before.

Section	Original Clause	New Clause (as amended)	What Exactly Changed
Sec. 58 Failure to surrender certificate of registration	Punishable with fine which may extend to ₹50,000, and in case of a continuing offence, an additional fine which may extend to ₹5,000 per day after the first day during which the offence continues.	Liable to penalty which may extend to ₹50,000, and in case of a continuing contravention, an additional penalty which may extend to ₹5,000 per day after the first day during which the contravention continues.	Straightforward decriminalisation. The terms “punishable”, “fine”, and “offence” are replaced with “liable”, “penalty”, and “contravention”, moving this from a criminal-fine provision—previously triable only by a Metropolitan or Judicial Magistrate—to a penalty that can be adjudicated departmentally. The monetary amounts remain unchanged.
New Sec. 58A Adjudication of penalties	No equivalent provision existed.	New section inserted: the Chairperson of the State Council is the adjudicating authority for penalties under Sec. 58, with the Chairperson of the Commission stepping in where no State Council yet exists. An aggrieved person may appeal within 30 days to the Chairperson of the Commission, or to a Central Government-nominated Secretary where the Commission’s Chairperson was the original adjudicator. Appeals must be disposed of within 60 days, and unpaid penalties are recoverable as arrears of land revenue.	Creates a complete adjudication and appeal framework from scratch, replacing reliance on criminal courts with a departmental mechanism. This section operationalises the decriminalisation introduced in Sec. 58.
Sec. 66(2) Power to make regulations	Clause list under sub-section (2) ended at clause (u).	Two new clauses inserted after (u): clause (ua) empowers regulations on the manner of holding inquiries and imposing penalties under Sec. 58A(1); clause (ub) empowers regulations on the form and manner of preferring an appeal under Sec. 58A(2).	Purely consequential. Grants the Commission explicit regulation-making powers to prescribe the procedures governing inquiries, penalties, and appeals under the newly inserted Section 58A.

4. The Clinical Establishments (Registration and Regulation) Act, 2010

This is the Act most directly relevant to hospitals, nursing homes and clinics, and it rewrites the corporate-liability provision. The actual rupee amounts for non-registration or non-compliance stay the same, but every violation moves out of the criminal-offence framework and into a civil-penalty framework. In practice, this usually means faster, non-custodial enforcement, without a criminal record attaching to the establishment or its officers.

Section	Original Clause	New Clause	What Exactly Changed
40 Penalty	Punishable: first offence, fine up to ₹10,000; second offence, fine up to ₹50,000; subsequent offence, fine up to ₹5 lakh.	Liable: first contravention, penalty up to ₹10,000; second contravention, penalty up to ₹50,000; subsequent contravention, penalty up to ₹5 lakh.	The penalty amounts remain unchanged. Only the legal character changes from criminal “fine/offence” to civil “penalty/contravention”.
41(3) Monetary penalty for non-registration	Cross-referred to “under sub-sections (1) and (2)”.	Cross-refers to “section 40, sub-sections (1) and (2) of section 41, and section 43 and sub-sections (1) and (2) of section 44”.	The cross-reference is significantly broadened to align with the renumbered and restructured penalty provisions.
43 Penalty for minor deficiencies	Punishable with fine.	Liable to penalty.	Terminology is updated, decriminalising this provision by replacing criminal-fine language with a civil penalty.
44 Contravention by companies	Corporate contravention provision in its earlier form.	Substituted: restates corporate liability so that both the company and the person in charge are liable under the same escalating penalty structure (₹10,000 / ₹50,000 / ₹5 lakh). Retains the due-diligence defence and continues liability for directors, managers, and officers where the contravention results from their consent, connivance, or neglect.	Completely rewrites the corporate liability provision using “penalty/contravention” terminology while preserving the substantive due-diligence defence.
46 Recovery of fine	Used the term “fine” throughout the section.	The term “fine” is replaced with “penalty” throughout.	A global terminology substitution reflecting the shift from criminal fines to civil penalties.

Why Is This Amendment Significant for Regulatory Compliance?

In our experience advising pharma and healthcare clients for over two decades, decriminalisation on paper does not always translate into lighter enforcement in practice, and that is exactly why this amendment deserves close attention rather than a sigh of relief. The most significant shift is structural. Routine lapses, registration defaults, cosmetics labelling or quality issues, pharmacist and allied-professional registration defaults, move out of magistrate courts and into the hands of internal adjudicating officers. This is faster, and it removes the stigma and delay of a criminal proceeding for what is often a paperwork failure. But it also removes the criminal-court threshold that, in practice, made regulators think twice before initiating action. A departmental penalty is quicker to impose than a criminal prosecution. Faster resolution can also mean more frequent enforcement, not less. The second point we would flag to clients is that the money is not moving in one direction. Drugs and Cosmetics Act penalties rise sharply, in some cases 15 to 25 times the earlier amount. Pharmacy Act penalties rise roughly 100 times from a colonial-era figure that had simply been left unrevised for decades. Clinical Establishments Act penalty amounts are unchanged in rupee terms, only their legal character shifts from criminal to civil. So while the word “decriminalisation” suggests things are getting easier, the actual cost of non-compliance is getting steeper for several of these laws. Third, the Section 3 escalator means compliance budgeting cannot be a one-time exercise. Penalty exposure under these laws will increase automatically every three years unless the specific Act has its own revision clause. This is the kind of detail that gets missed in an initial reading of the Act and then becomes a problem three years later.

What Is the Impact on the Pharma, Pharmacy and Healthcare Industry?

For pharma manufacturers, this means cosmetics-related compliance can now be resolved departmentally, which is a genuine relief operationally, but drug-quality violations under section 33-I still carry the possibility of imprisonment, and now come with a much higher penalty attached. Quality and regulatory teams should not read this Act as a general softening of drug-quality enforcement. It is not that. It is a recalibration that separates technical and cosmetics-related defaults from genuine drug-quality risk, and increases the cost of the latter. For pharmacists, pharmacy establishments and allied health professionals, the registration-surrender default under both the Pharmacy Act and the Allied and Healthcare Professions Act is now a modernised, escalating penalty rather than a nominal fine. This is one area where the change is more procedural than financially painful, though the numbers are still meaningfully higher than before, and both Acts now have a full departmental adjudication and appeal process where none existed earlier. For hospitals, nursing homes and clinics operating under the Clinical Establishments Act, the practical effect is that non-registration or non-compliance no longer exposes promoters, directors or administrators to a criminal record. This is a real change in personal risk profile for the people running these establishments, even though the penalty amount itself has not moved. Across all four laws, we would advise compliance teams not to treat this as a deadline they can push down the priority list. Commencement dates are being notified separately for each Act under Section 1(2) of the 2026 Act, and different provisions will come into force on different dates. The Drugs and Cosmetics Act provisions we have discussed above, for instance, come into force on June 30, 2027, not immediately. Track the Official Gazette for the specific notification applicable to each law before assuming any of these changes are currently in effect, and build the automatic 10% escalator into your three-year compliance cost projections now, rather than after the first revision catches you off guard.

Our View

Jan Vishwas 2.0 is a welcome development for companies tired of disproportionate criminal exposure for technical defaults. But it rewards close reading, not a quick skim. The shift from courts to departmental officers can work in your favour if your compliance processes are already sound, and can work against you if they are not, since departmental adjudication tends to move faster than criminal litigation ever did. If your compliance calendar has not yet been updated to reflect the different commencement dates and the changed penalty amounts under each of these four Acts, that is the first thing to fix.

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Tags: Jan Vishwas 2.0, Drugs and Cosmetics Act, Pharmacy Act, Clinical Establishments Act, Decriminalisation, Regulatory Compliance

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