An independent pharmaceutical consultant's perspective on the proposed amendments to Rules 85 and 122O of the Drugs Rules, 1945
By Rajesh Kapoor | Independent Pharmaceutical Consultant | 28+ Years of Pharmaceutical Industry Experience
The Indian pharmaceutical industry has made tremendous progress over the years in strengthening manufacturing standards, improving quality systems and establishing itself as a globally recognised supplier of medicines. However, this progress also brings with it an enormous responsibility: ensuring that every medicine reaching a patient meets the prescribed standards of quality, safety and efficacy.
Having spent over 28 years in the pharmaceutical industry, including leadership responsibilities in Quality and Regulatory Affairs and now working as an independent pharmaceutical consultant, I have consistently advocated stronger GMP compliance, improved manufacturing practices, robust Quality Management Systems and continuous upgradation of pharmaceutical facilities.
I have always believed that there should be no compromise when it comes to patient safety.
However, after reviewing the recently published Draft Drugs (Amendment) Rules, 2026, vide G.S.R. 956(E), dated 28 October 2026, I believe that certain proposed provisions deserve serious reconsideration before they are finalised.
My concern is not about strengthening pharmaceutical regulation. On the contrary, I strongly support it.
My concern is about the proposed mechanism of enforcement, particularly the provision for immediate suspension of the manufacturing licence granted for the particular drug upon receipt of a Government Analyst's report declaring that drug Not of Standard Quality (NSQ).
Can we strengthen patient safety without creating disproportionate consequences for pharmaceutical manufacturers? I believe we can, and we should.
1. What Exactly Is the Government Proposing?
The Ministry of Health and Family Welfare has proposed amendments to Rules 85 and 122O of the Drugs Rules, 1945.
The proposed Rule 85(2A) and Rule 122O(1A) introduce provisions requiring the Central Licensing Approving Authority or State Licensing Authority, as applicable, to immediately suspend the manufacturing licence granted for the particular drug upon receipt of a Government Analyst's report declaring that drug Not of Standard Quality.
Under proposed Rule 85(2A), the specified parameters include:
Assay
Dissolution
Related substances
Impurities
Sterility
The proposed Rule 122O(1A) provides a broader provision relating to drugs declared NSQ.
The suspension would continue until the manufacturer conducts an effective root cause analysis and implements Corrective and Preventive Actions (CAPA) to the satisfaction of the licensing authority.
The suspension would be revoked only after implementation and verification of CAPA.
An important clarification: The proposed provisions refer to the manufacturing licence granted for the particular drug concerned. They do not expressly propose automatic suspension of all manufacturing permissions held by the company or closure of the entire manufacturing facility.
This distinction must be clearly understood while evaluating the proposed amendment.
Nevertheless, suspension of permission to manufacture even a single product can have significant consequences, particularly when that product represents a substantial portion of the manufacturer's business, serves an important therapeutic segment or has limited alternative manufacturing sources.
At first glance, the proposed measure may appear to be a strong and decisive step towards preventing substandard medicines from reaching patients.
However, the implications of making suspension an immediate and mandatory consequence of an analytical report need to be examined carefully.
2. A Laboratory Failure and a Manufacturing System Failure Are Not Necessarily the Same
This is an important distinction that deserves attention.
A Not of Standard Quality result is a serious matter and must never be ignored. Every NSQ result should trigger a documented investigation, scientific assessment and appropriate regulatory response.
However, not every NSQ result necessarily establishes that the entire manufacturing system has failed.
Consider a few examples:
A batch failing assay specifications.
A dissolution result falling outside the prescribed limits.
An isolated impurity exceeding its specified acceptance criterion.
A sterility failure.
A result potentially influenced by sampling, transportation, storage or analytical variables.
These situations are not scientifically identical.
A sterility failure, for instance, can represent an immediate and potentially serious patient-safety risk. An assay or dissolution failure may require a different level of investigation depending on the magnitude, nature and possible cause of the failure.
The investigation may identify a manufacturing process problem, an analytical issue, a raw-material variation, an equipment-related problem or another contributing factor.
The regulatory response should therefore consider the nature of the failure, its severity and its potential impact on patients.
Should an isolated batch-level failure automatically result in suspension of the manufacturing permission for that particular product without first assessing the circumstances and extent of the failure?
I believe this question deserves serious consideration.
3. Does the Proposed Mechanism Adequately Protect Statutory Rights Under the Drugs and Cosmetics Act, 1940?
One of my major concerns relates to the existing statutory mechanism under Section 25 of the Drugs and Cosmetics Act, 1940.
Section 25(3) provides a statutory opportunity to dispute the findings of a Government Analyst within 28 days of receiving the report by giving written notice of the intention to adduce evidence in controversion.
Section 25(4) provides for examination of the sample through the Central Drugs Laboratory in the circumstances specified therein, with the Director's report having the statutory evidentiary status provided under that section.
This is an important safeguard within the existing legislative framework.
The Supreme Court of India, in M/s Medicamen Biotech Ltd. & Anr. v. Rubina Bose, Drug Inspector, Criminal Appeal No. 483 of 2008, decided on 13 March 2008, recognised the importance of the manufacturer's statutory rights under Sections 25(3) and 25(4).
The judgment highlighted the serious consequences of procedural delays when a manufacturer seeks re-analysis and the drug sample approaches the end of its shelf life.
My concern is that the proposed amendments do not expressly explain how these statutory rights will be protected when an NSQ report is disputed.
What happens if a manufacturer receives an NSQ report, disputes the analytical findings within the statutory period and seeks examination through the Central Drugs Laboratory?
Will the product-specific manufacturing permission remain suspended regardless of the outcome of that statutory challenge?
What happens if the subsequent examination does not support the original Government Analyst's finding?
These questions should be addressed explicitly in the amended rules.
I am not suggesting that a manufacturer should be allowed to continue distributing a potentially unsafe product merely because it has disputed a test result. Patient protection must always take priority.
However, an appropriate mechanism must exist to protect the manufacturer's statutory right to challenge an analytical finding while allowing regulators to take necessary interim action wherever justified.
4. Product-Specific Suspension: Is an Automatic Decision Always Justified?
I would like to clarify that the proposed amendment is not about automatically suspending the entire manufacturing licence of a pharmaceutical company.
The language of the proposed Rule 85(2A) and Rule 122O(1A) refers to suspension of the manufacturing licence granted to manufacture the particular drug concerned.
Therefore, if a company manufactures several products, an NSQ finding against one product would trigger the proposed suspension mechanism in relation to the manufacturing permission for that particular drug, rather than automatically stopping the manufacture of every other product.
This is an important distinction, and the impact of the proposed amendment should be evaluated accordingly.
However, even a product-specific suspension can have substantial consequences.
Consider a manufacturer producing several pharmaceutical formulations, with one particular product contributing significantly to its business or catering to a critical therapeutic requirement.
Suspension of permission to manufacture that product could result in:
Disruption of production and supply commitments for that particular product.
Financial losses arising from blocked production and inventory.
Contractual difficulties with marketing companies and distributors.
Disruption of supply to patients who depend on that medicine.
Additional regulatory and operational costs associated with investigations and CAPA.
Loss of confidence among customers and business partners.
More importantly, the suspension could continue even when the manufacturer is disputing the analytical findings through the statutory procedure.
The fundamental question is not whether a product-specific suspension can be imposed. It is whether making that suspension automatic, without expressly addressing the circumstances of the case and the statutory challenge mechanism, is the most appropriate regulatory approach.
A product-specific NSQ finding should certainly invite stringent scrutiny of the affected product and its manufacturing process.
However, the regulatory response should also consider the nature of the failure, the associated risk, the manufacturer's quality history and the findings of the investigation.
5. CAPA Is a Scientific Process, Not Merely an Administrative Formality
Every pharmaceutical professional understands the importance of root cause analysis and CAPA.
In fact, I have spent a substantial part of my professional career implementing and improving pharmaceutical Quality Management Systems, strengthening CAPA procedures and preparing organisations for regulatory inspections.
However, an effective CAPA is not always something that can be completed within a few days.
Depending on the nature of the problem, it may require:
Detailed investigation of manufacturing and testing records.
Review of process parameters and critical quality attributes.
Equipment maintenance, modification and requalification.
Process revalidation.
Analytical method investigation and verification.
Supplier and raw-material investigations.
Stability evaluation.
Training and competency reassessment.
Effectiveness verification over subsequent batches.
Some corrective actions can be completed immediately, while preventive actions and effectiveness verification may require a longer period.
If suspension continues until every aspect of CAPA is completed to the satisfaction of the licensing authority, without a defined review mechanism or reasonable regulatory timeline, manufacturers could face prolonged uncertainty.
The draft should therefore distinguish between immediate corrective measures required to control the identified risk and longer-term CAPA effectiveness verification.
It should also provide a transparent mechanism for review and restoration of manufacturing permissions when the immediate risk has been adequately addressed.
6. The Wider Consequences for the Pharmaceutical Industry
India is one of the world's major pharmaceutical manufacturing and supply centres.
The industry comprises large pharmaceutical companies, mid-sized manufacturers, small-scale manufacturers, loan licensees and contract manufacturing organisations.
These companies operate with substantial investments in infrastructure, machinery, quality-control laboratories, trained manpower and regulatory compliance.
Although the proposed suspension is product-specific, its consequences can extend beyond the affected batch.
Impact on manufacturing operations: Production schedules and supply commitments relating to the affected product can be disrupted.
Impact on employees: Personnel directly involved in manufacturing, quality assurance, quality control, warehousing and related activities for the affected product may be impacted.
Impact on medicine availability: Products with limited alternative sources may face supply disruptions.
Impact on business sustainability: Manufacturers may experience financial losses, particularly where the affected product contributes significantly to their business.
Impact on India's pharmaceutical competitiveness: Uncertainty in regulatory enforcement can affect manufacturing investments, contract manufacturing relationships and confidence among international customers.
None of these consequences should be used as an excuse for poor-quality manufacturing.
But a balanced regulatory framework must consider the overall public interest, which includes both the quality of medicines and their continued availability.
7. Is the Proposed Amendment Consistent with the Existing Regulatory Framework?
The existing Rule 85 and Rule 122O provide for suspension or cancellation of licences through prescribed procedures, including an opportunity to show cause and a written order stating the reasons.
The proposed provisions introduce an overriding mechanism through the expression "Notwithstanding anything contained in sub-rule (1) and (2)" under Rule 85 and "Notwithstanding anything contained in sub-rule (1)" under Rule 122O.
This creates an important regulatory and legal question.
The Drugs and Cosmetics Act, 1940, empowers the Central Government to frame rules. However, rules made under a parent legislation must operate consistently with the Act and its statutory framework.
In my view, the proposed amendments require closer examination regarding their interaction with:
The statutory rights under Section 25.
The existing procedural safeguards under Rules 85 and 122O.
The principles of natural justice.
The proportionality of regulatory action.
The distinction between precautionary action and final adverse action.
The objective of protecting public health is unquestionably legitimate. However, the manner in which that objective is pursued must also be legally sustainable.
There is also an apparent drafting inconsistency in proposed Rule 122O(1AA), which refers to suspension under sub-rule (2A), although the corresponding new provision is numbered (1A). This should be corrected before finalisation.
These concerns warrant detailed legal examination rather than a premature conclusion that the proposed provisions are necessarily invalid.
8. What Would Be a More Balanced Regulatory Approach?
I strongly believe that India needs stringent and effective pharmaceutical regulation. However, I would suggest the following improvements before these amendments are finalised.
1. Risk-based regulatory action
The response should depend on the nature, severity and potential patient-safety implications of the NSQ finding.
2. Immediate batch-level protection
Where there is a potential public-health risk, the authorities should have the ability to immediately restrict distribution, order recall or take other necessary precautionary measures.
3. Protection of statutory retesting rights
The procedure under Section 25(3) and Section 25(4) should be expressly preserved, with prompt communication and preservation of samples under appropriate conditions.
4. Opportunity for a reasoned regulatory decision
Except where an immediate emergency measure is demonstrably necessary, the manufacturer should receive a reasonable opportunity to explain the findings and present its investigation.
5. Differentiation between batch failure and systemic failure
Suspension of the manufacturing permission for a particular product should not be an automatic consequence of every isolated batch-level NSQ result without consideration of its cause and wider implications.
6. Defined timelines for regulatory review
The licensing authority should review the suspension and the manufacturer's response within specified timelines.
7. Clear CAPA closure requirements
The regulatory authority should distinguish between immediate risk-control actions, corrective actions and long-term effectiveness verification.
8. A mechanism for review and restoration
Where subsequent statutory examination or a scientific investigation does not substantiate the original finding, there should be a clear mechanism for reconsidering and, where appropriate, revoking the suspension.
These measures would strengthen enforcement without unnecessarily compromising the rights of manufacturers or disrupting the pharmaceutical supply chain.
9. My Message to the Pharmaceutical Industry
I would also like to make one thing absolutely clear.
This article is not an argument in favour of manufacturers who neglect quality systems, ignore repeated deviations, manipulate analytical results or release products that do not meet prescribed standards.
Such practices must attract strict regulatory action.
Every pharmaceutical manufacturer must take ownership of its quality systems. GMP compliance should not be treated as a documentation exercise or something to be implemented only before an inspection.
Quality must be built into every stage of pharmaceutical manufacturing.
However, regulatory enforcement should distinguish between deliberate non-compliance, systemic quality failures, isolated batch defects and genuine analytical or procedural disputes.
A regulatory framework that is scientifically informed, transparent and proportionate will encourage better compliance and greater confidence among all stakeholders.
The pharmaceutical industry should also use this opportunity constructively by submitting well-reasoned suggestions and technical representations to the Ministry within the prescribed consultation period.
Silence should not be mistaken for agreement when an important regulatory change has far-reaching implications.
10. My Concluding Perspective: Stronger Regulation, But With Balance
After more than 28 years in this industry, I have seen how pharmaceutical manufacturing has evolved and how much effort companies have invested in upgrading facilities, strengthening quality systems and aligning with international GMP expectations.
I have always supported improvements. I continue to advocate higher standards, better compliance and stronger accountability.
But I also believe that good regulation must achieve a balance between patient safety, scientific evidence, statutory rights and the practical realities of pharmaceutical manufacturing.
A medicine that does not meet quality standards must never be allowed to compromise patient safety. Equally, a manufacturer's product-specific manufacturing permission should not be suspended without a fair, scientifically justified and legally sustainable assessment of the circumstances.
The objective should not be to make regulation less stringent.
The objective should be to make regulation more effective, more transparent and more balanced.
I sincerely hope the Ministry of Health and Family Welfare will reconsider the proposed provisions in consultation with pharmaceutical manufacturers, regulatory experts, pharmacists, quality professionals and legal experts before finalising the amendments.
India needs a pharmaceutical regulatory framework that protects patients, strengthens the industry and reinforces the global credibility of Indian medicines.
Patient safety and a sustainable pharmaceutical industry are not opposing objectives. With the right regulatory framework, both can and must go hand in hand.
About the Author
Rajesh Kapoor is an independent pharmaceutical consultant and founder of PharmaHealth Insights, with over 28 years of experience in the pharmaceutical industry.
His professional experience spans Quality Assurance, Quality Control, Regulatory Affairs, cGMP compliance, pharmaceutical manufacturing, Quality Management Systems, regulatory inspections and facility upgradation.
Through PharmaHealth Insights, he works with pharmaceutical manufacturers to strengthen quality systems, improve regulatory compliance, implement GMP requirements and build sustainable quality practices.
Disclaimer: This article represents the author's independent professional opinion based on the proposed draft rules and his pharmaceutical industry experience. The legal issues discussed are intended to encourage regulatory and industry discussion and do not constitute a formal legal opinion.
References
Ministry of Health and Family Welfare, Government of India. G.S.R. 956(E), dated 28 October 2026 – Draft Drugs (Amendment) Rules, 2026.
Drugs and Cosmetics Act, 1940 – Section 25.
Drugs Rules, 1945 – Rules 85 and 122O.
M/s Medicamen Biotech Ltd. & Anr. v. Rubina Bose, Drug Inspector, Criminal Appeal No. 483 of 2008, Supreme Court of India, judgment dated 13 March 2008.
