A panel uniting CDSCO’s Deputy Drugs Controller, the US Pharmacopeia’s India head, the Indian Pharmacopoeia Commission’s senior scientific officer, and FDC Limited’s regulatory lead delivers an extraordinarily frank account of what revised Schedule M means, what it demands, and why — for the first time in two decades — the regulatory and industry communities are genuinely aligned on the answer, Rashmi Kumari of Neo Science Hub, reports
A regulatory panel that places the official who helped draft a new law in the same room as the companies that must now comply with it, the international pharmacopoeial body whose standards it partially mirrors, and the national standards institution whose publications it cross-references — and that does so in a public forum at a trade fair — is either a very unusual event or a very mature industry. The Schedule M regulatory session at analytica Lab India x PharmaCore India 2026 on Day 2 was, by any measure, both.
The session — titled “Schedule M: What’s New? Regulatory Updates” — ran from 12:15 PM as the first panel of the afternoon block, moderated by Dr. Rajiv Desai of the Indian Pharmaceutical Alliance (IPA), and featured four panellists whose institutional affiliations together covered every layer of the regulatory, standards, and industrial compliance architecture: Dr. Santosh Indraksha, Deputy Drugs Controller (India) at CDSCO, Ministry of Health and Family Welfare, currently heading the West Zone office at Mumbai, who played a direct role in formulating the revised rules; Dr. Girish Kapur, Senior Vice President of India Site Operations at the United States Pharmacopeia (USP), whose Hyderabad facility celebrated 20 years of operations in India in the same week; Dr. Gaurav Pratap Singh Jadaun, Senior Scientific Officer at the Indian Pharmacopoeia Commission (IPC), Ministry of Health and Family Welfare, Ghaziabad, representing the institution that sets India’s official drug standards; and Dr. Rupesh Kelaskar, Senior Quality and Regulatory professional from FDC Limited, Mumbai — one of India’s most experienced regulated-market pharmaceutical manufacturers — representing the industry voice at the table.
What Schedule M Actually Changed
Dr. Indraksha opened the substantive discussion with a correction that the industry has needed to hear plainly for several years. The dominant narrative around revised Schedule M — notified through GSR 922(E) on December 28, 2023, and made mandatory for all manufacturers from January 1, 2026 — has been one of dramatic disruption: new infrastructure requirements, prohibitive capital expenditure for MSMEs, and a compliance bar set beyond the reach of smaller manufacturers. This narrative, Dr. Indraksha argued with the authority of the person who actually drafted the rules, is a myth.
“There is a myth that the revised schedule is something drastically different from the earlier one,” he told the panel and audience. “Actually it is not.” The elements of the 2024 revision that represent genuinely new requirements are not structural or infrastructural. The old schedule — amended in 2004 and implemented in 2008 — already mandated HVAC systems, airlocks, process validation, and recall mechanisms. What the revision adds is principally documentation rigour: the requirement to generate, maintain, and demonstrate documented evidence of the quality activities that the industry was theoretically already performing. Design qualification, operational qualification, performance qualification for HVAC and critical utilities. Computerised system validation, conspicuously absent from the 2008 version because the technology was not yet prevalent. Data integrity requirements, which were, as Dr. Indraksha noted with dry precision, “the underlying principle” of the old schedule even without explicit mention: “that does not mean that anybody can fabricate the data, right.”
The actual challenge of the revision, he argued, is not for companies that were genuinely compliant with the old schedule — for them, the transition is “mere shifting from having any newer requirement in terms of infrastructure to a more calibrated and documented approach.” The challenge is for companies that were never actually compliant with the old requirements to begin with. “There would be a problem for an industry which currently was not complying to the old schedule.”
CDSCO’s response to this challenge was multidimensional. Capacity-building seminars for Schedule M compliance were conducted across zones. The Department of Pharmaceuticals established the RPQS (Raising the Profile of Quality Standards) scheme, providing two-crore-rupee subsidies to MSME manufacturers for compliance-related capital investment. A compliance extension of one year was granted to manufacturers who applied for it under GSR 127(E) of February 2025, with mandatory enforcement following for all from January 2026. Despite repeated advisories and directives from CDSCO and State Licensing Authorities, it was estimated that only 10 to 12 per cent of manufacturing firms applied for such an extension — a figure that suggests the majority either were already compliant or chose to proceed directly without deferral.
“Government of India actually wanted to promote the pharmaceutical industry,” Dr. Indraksha concluded. “If you are not a quality-oriented organisation, you will not survive in the competition. Revised Schedule M is giving its results. It is giving its results because the trust is building.”
From Testing-Driven to System-Driven
Dr. Rupesh Kelaskar of FDC Limited offered the industry practitioner’s translation of what the revision means at the operational level — and the framing he chose was definitional rather than descriptive: “If you ask me to define it, I can say it is now from a testing-driven to a compliance-driven — maybe a system-driven — approach.”
The distinction matters enormously. A testing-driven approach means that quality is established at the point of final product release — the batch is tested, it passes, it ships. A system-driven approach means that quality is built into the manufacturing process at every stage, continuously monitored, continuously documented, continuously verified. The entire structure of revised Schedule M — its emphasis on pharmaceutical quality systems, continuous process verification, data integrity, vendor qualification protocols, and the formal ownership of manufacturing processes rather than mere adherence to batch manufacturing records — is the regulatory codification of this shift.
FDC’s position in this conversation was instructive. The company holds US-FDA, UK-MHRA, MCC-RSA, and UAE regulatory approvals across its manufacturing facilities in Roha, Waluj, Sinnar, Verna, and Baddi, and has substantial experience in Schedule M-equivalent compliance frameworks for regulated export markets. Dr. Kelaskar was explicit that for companies already operating in regulated markets, the revised schedule introduces no requirements that are genuinely unfamiliar. The capital investment requirements, where they exist, centre on HVAC systems with contamination control strategy integration, data integrity platforms meeting 21 CFR Part 11 standards, and the professional development of “knowledgeable and skillful people” — which he identified as “the most required” investment of the three.
The patient safety framing he chose for his close was striking in its simplicity: “This is everything what has been done is nothing but to the concern of the patient, so they can have safe and effective medicines. Spurious medicines can be attacked, they can be controlled. When any patient taking medicine is consuming it with the fact in mind that he is going to get cured — implementation of Schedule M thoroughly is going to definitely help him. Schedule M is more about gaining confidence of patients, and industry has to contribute to it.”
The Pharmacopoeia: Standards for 22 Countries and the Vision for More
Dr. Girish Kapur of USP, whose institution has operated in India for 20 years and transformed USP’s Hyderabad facilities from a lab-focused operation into a thriving hub of more than 300 staff delivering critical operations across science, quality assurance, customer experience, and data analytics, brought the session’s most structurally important external reference point: the direct relationship between Schedule M compliance and the quality of material donations from Indian industry to USP’s reference standard development programmes.
USP’s standard-setting process, Dr. Kapur explained, depends substantially on physical material donations from industry — including from Indian MSMEs — for characterisation and standard development both in Hyderabad and at USP’s Rockville headquarters. The quality of those donations determines how efficiently standards can be developed. Revised Schedule M’s emphasis on quality systems, documentation, and computer system validation means that the MSMEs making those donations will, over time, supply better-characterised, better-documented materials. The quality standard improvement is therefore self-reinforcing: better-compliant manufacturers supply better reference materials; better reference materials enable more rigorous standard-setting; more rigorous standards protect patients globally.
He positioned the revised Schedule M within India’s broader pharmaceutical export ambitions with clinical precision: India’s pharmaceutical market stands at $55 billion, with more than half derived from exports and 40 per cent of those exports going to the US. The aspiration, widely shared across the industry, is to grow to $120–130 billion within four to five years. “That can only happen if the quality standards are elevated,” he said. “This is what Schedule M is supposed to do.”
His most consequential observation of the session came in the training and competency-building discussion, where he identified mindset as the missing variable that skillset and toolset training alone cannot address: “Most of the training requirements are directed towards skillset and toolset. But mindset is something which all of us have to work on.” He connected this explicitly to the preceding AI master class by Amit Jadhav — “the cycle of learn, unlearn and relearn” — arguing that the toughest part of any transformative compliance requirement is unlearning the practices of the previous paradigm. “Once you unlearn, the relearning becomes very easy.”
His USFDA warning letter alert to the audience — citing the issuance, “day before yesterday,” of the first-ever FDA warning letter related to AI use in pharmaceutical manufacturing — was the session’s sharpest moment of regulatory intelligence. “AI can be used as a supporting tool, but not without human intervention,” he told the panel. “Please read that warning letter. It’s on the USFDA website.” The timing — delivered immediately after a 90-minute AI master class in the same session — was precise and intentional: capability without accountability is exactly the compliance failure the revised Schedule M is designed to prevent.
The Pharmacopoeia Commission
Dr. Gaurav Pratap Singh Jadaun of IPC positioned the revised Schedule M explicitly within the Government of India’s Viksit Bharat 2047 vision — making the regulatory conversation not merely a compliance exercise but a national development strategy. IP 2026, the 10th edition of the Indian Pharmacopoeia released by Union Health Minister Shri J.P. Nadda, becomes effective July 1, 2026, and represents the most comprehensive harmonisation of Indian drug standards with global pharmacopoeial benchmarks to date.
IPC, he explained, is actively working to harmonise its general chapter requirements with the Pharmacopoeial Discussion Group (PDG) texts — the same standards frameworks used by USP, the European Pharmacopoeia, and the Japanese Pharmacopoeia — so that a significant proportion of IP 2026’s standard content is directly aligned with the global frameworks followed in Europe, the US, and Japan. The IP is now recognised by 22 countries, with more recognitions being negotiated, and the IP online portal — which Dr. Jadaun indicated will progressively replace the physical publication — makes those standards continuously accessible rather than periodically revised.
The ICH membership question — raised by Dr. Desai, who noted that India’s name does not yet appear in the Pharmaceutical Inspection Convention (PIC/S) roster and that full ICH membership remains aspirational — received a carefully structured answer from both Dr. Indraksha and Dr. Jadaun. India signalled its intent to become an ICH member in 2016 and has since participated in the required assembly meetings. The constraint on full adoption is not political but practical: a large segment of India’s manufacturing industry does not yet have the infrastructure capacity to adopt the full suite of ICH guidelines simultaneously. The revised Schedule M, Dr. Indraksha argued, is precisely the progressive step that enables ICH membership to become achievable without imposing a compliance shock on the MSME sector.
On PIC/S membership — the Pharmaceutical Inspection Co-operation Scheme whose member countries benefit from mutual recognition of GMP inspections — Dr. Kelaskar of FDC offered a direct, experienced answer: “If you are complying with Schedule M to the best you can, I don’t think there will be much issue complying to PIC/S.” FDC’s own experience with PIC/S inspections and Russian pharmaceutical authority (Roszdravnadzor) inspections both confirmed that presenting WHO guidance-aligned documentation was sufficient to satisfy overseas inspectors: “When we gave clarity on some of the observations with respect to the WHO guidance, even they accepted.”
The CDSCO’s bilateral MOU programme — with agreements signed with USFDA, MHRA, DFAM, PMDA, and approximately 24 countries in total, covering information exchange, training, and observed inspection programmes — was presented by Dr. Indraksha as the institutional infrastructure through which mutual GMP inspection recognition can eventually be achieved, reducing the repeated inspection burden that currently absorbs significant resources from Indian manufacturers operating across multiple regulated export markets.
The ONDLS Question
In a moment that few conference panels manage — genuine responsiveness to an audience question that had not been pre-scripted — Dr. Indraksha closed the session with a direct offer to the assembled pharmaceutical manufacturers. The Online Drug Licensing System (ONDLS) — CDSCO’s digital platform for WHO-GMP certificates, Certificates of Pharmaceutical Products (CoPP), and manufacturing authorisations — had, by the session’s own admission, been generating difficulties for industry users navigating the upcoming digitisation of regulatory processes.
“My office is there in the Mumbai Centre,” Dr. Indraksha told the audience. “If you are having any issues with the ONDLS for the WHO GMP or CoPP or upcoming module on manufacturing, kindly contact. Visit my office, or take my number from the organisers. WhatsApp me the issue with your company’s name and mobile number. We will take it forward, and I will try to resolve it instantaneously.” The qualifier — “instantaneously means a day or two” — was delivered with a self-awareness that drew laughter from an audience familiar with government digital systems, but the underlying offer was genuine and practically significant: a senior CDSCO official, publicly, at a trade fair, inviting direct digital contact from industry for real-time regulatory process resolution.
CDSCO, he noted, has since 2015 moved almost all 100 per cent of its processes online under the Digital India initiative, and has already issued approximately 100 per cent of its certificates digitally. “You don’t have to worry. Our offices at regional level are there to help you.”
SIDBI, Funding, and the MSME Gap
The session’s audience Q&A produced one substantive exchange worth recording. A senior IDMA MSME Committee representative — Dr. Vaidya, identified in the transcript as MSME Chairman of the Indian Drug Manufacturers Association — raised the funding gap directly: the two-crore RPQS subsidy from the Department of Pharmaceuticals is insufficient for the capital investment required in many cases, and a banking pathway is needed. He disclosed that IDMA has already held discussions with SIDBI (Small Industries Development Bank of India), which has expressed readiness to provide five to ten crore loans calibrated to individual MSME requirements — but requires a formal CDSCO circular to activate the mechanism.
Dr. Indraksha’s response was transparent about its limits and clear about its pathway: “That is a policy matter, beyond my authority. But informally, CDSCO is there for industry support. Write to me. I will take it forward to my higher-ups.” The SIDBI–CDSCO loan facilitation circular — if it materialises — would represent a structural resolution of the MSME capitalisation problem that revised Schedule M has exposed, and the informal endorsement of the concept by a senior CDSCO official in a public forum is a meaningful step toward that outcome.
The Crown and Those Who Would Wear It
Dr. Desai’s closing remarks brought the session’s logic to its conclusion. The rigor of CDSCO inspector training — which Dr. Indraksha confirmed is now being conducted through intensive five-day professional development programmes for inspectors across the country — will, in the coming period, produce inspection outcomes that are genuinely comparable to what overseas regulatory agencies deliver. “The rigor of inspection by the CDSCO is going to go up, which will be at par with what we see from the overseas regulatory agencies.”
This, ultimately, is what revised Schedule M is building toward: not merely a document that Indian pharmaceutical manufacturers must comply with, but a domestic regulatory ecosystem whose inspection standards, reference standards, international recognitions, and industry capability are aligned to the point where the phrase “pharmacy of the world” means not just that India manufactures medicines at scale, but that those medicines are manufactured to the highest verifiable quality standard available anywhere.
“We will make and retain the crown of pharmacy of the world,” Dr. Indraksha said, near the end of his contribution to the session. It was the kind of statement that could sound like political rhetoric if said elsewhere. At a panel where the person saying it had personally helped draft the regulatory instrument that might actually make it true, it sounded like a commitment.
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