**Executive Summary**
This report outlines regulatory reforms by the Ministry of Health and Family Welfare and the CDSCO to streamline drug manufacturing, testing, and approval processes in India. Key measures include the transition to dossier-based licensing, the introduction of digital platforms like ONDLS, and the release of the Indian Pharmacopoeia 2026. These changes, underpinned by legislative amendments in early 2026, aim to reduce drug development timelines and enhance market surveillance.
**Key Points / Main Content**
**Regulatory Streamlining and Licensing**
* **Dossier-Based System:** A new guidance document (issued 25.02.2026) introduces dossier-based manufacturing applications to ensure transparency, fairness, and efficient decision-making.
* **Rule Amendments:** The New Drugs and Clinical Trials Rules, 2019, were amended (20.01.2026) to replace the requirement for Central Drugs Standard Control Organization (CDSCO) permission with a "prior intimation" system for manufacturing certain drugs for analysis and research.
* **Delegation of Power:** Powers under the Drugs and Cosmetics Act, 1940, have been delegated to Joint and Deputy Drugs Controllers to accelerate application disposal.
* **Export Simplification:** The validity of Free Sale Certificates is now aligned with manufacturing licenses, and prior permission for BA/BE studies for export drugs has been replaced by an online intimation mechanism (21.01.2026).
**Expedited Testing and Research**
* **Fast-Tracked NOCs:** No-Objection Certificates (NOCs) for laboratory testing are now granted immediately upon application receipt (as of 23.02.2026) to eliminate delays in prior technical scrutiny.
* **Animal Testing Reduction:** CDSCO now accepts pre-existing preclinical toxicity data to minimize redundant animal studies, with further requirements determined on a case-by-case basis.
* **Standardization:** The Indian Pharmacopoeia 2026 was released on 02.01.2026, incorporating new vaccines, blood products, and anti-tuberculosis medications.
**Digital Transformation and Oversight**
* **Digital Platforms:** The Online National Drugs Licensing System (ONDLS) serves as a single-window portal for manufacturing and sales licenses, while SUGAM Labs automates drug testing workflows.
* **Risk-Based Inspections:** Since December 2022, over 960 premises have undergone risk-based inspections, resulting in more than 860 regulatory actions, including license cancellations and stop-production orders.
* **Targeted Audits:** Intensive audits have been conducted for over 1100 cough syrup manufacturers and 380 blood centres.
**Infrastructure and Surveillance**
* **SSDRS Scheme:** ₹756 Crore has been released to States/UTs to upgrade drug regulatory systems, including the construction of 19 new drug testing labs and the upgrading of 28 existing ones.
* **Pharmacovigilance:** The National Coordination Centre for Pharmacovigilance Programme of India (PvPI) monitors post-market adverse events and provides safety recommendations to the CDSCO.
**Impact Analysis**
**Pharmaceutical Manufacturers and Exporters**
**Impact**
They benefit from significantly reduced regulatory timelines, lower procedural requirements for export-oriented studies, and a more transparent licensing process.
**Action Required**
Transition to the ONDLS portal for all license applications and comply with the updated standards in the Indian Pharmacopoeia 2026.
**Regulatory Authorities (CDSCO and State Controllers)**
**Impact**
Senior officers have increased administrative authority, and state departments have access to federal funding (SSDRS) for infrastructure upgrades.
**Action Required**
Maintain rigorous market surveillance, conduct risk-based inspections, and manage the automated workflows via SUGAM Labs.
**Research and Development (R&D) Institutions**
**Impact**
Researchers can obtain materials for analysis and trial purposes faster due to the removal of certain test license requirements and the acceptance of existing toxicity data.
**Action Required**
Utilize the "prior intimation" system for manufacturing drugs for research and analysis purposes and provide comprehensive preclinical data for reviews.
Key Entities Referenced
Central Drugs Standard Control Organization (CDSCO): The national regulatory authority responsible for implementing reforms such as dossier-based licensing, fast-tracking drug approvals, and conducting risk-based inspections of manufacturing premises.
New Drugs and Clinical Trials Rules, 2019: The primary regulatory framework amended to introduce a 'prior intimation' system, replacing the need for formal permission from the CDSCO for manufacturing drugs for testing purposes.
Indian Pharmacopoeia 2026: The updated official policy document containing the standards for new drugs, vaccines, and blood products introduced to enhance pharmaceutical quality control.
Strengthening of States’ Drug Regulatory System (SSDRS): A Centrally Sponsored Scheme focused on upgrading existing State drug laboratories and establishing new drug testing infrastructure across India.
Online National Drugs Licensing System (ONDLS): A single-window digital platform, along with the SUGAM Labs portal, introduced to automate and streamline the processing of drug licensing and testing workflows.
Ministry of Health and Family Welfare
Steps taken to Ease Regulatory Process and
Drug Testing
A dossier-based licensing system has been introduced to
make drug manufacturing approvals more transparent and
efficient
Approvals for new drugs have been fast-tracked by granting
immediate No-Objection Certificates for laboratory testing
An online intimation mechanism has replaced prior
permission for BA/BE studies of export drugs to reduce
regulatory delays
The Indian Pharmacopoeia 2026 has been released with the
inclusion of new drugs, vaccines, and blood products
The validity of Free Sale Certificates has been aligned with
the validity of manufacturing licenses to simplify export
processes
Pre-existing preclinical toxicity data is now accepted to
reduce the need for animal testing
Regulatory powers have been delegated to senior authorities
to speed up approvals and licensing
Digital platforms like ONDLS and SUGAM Labs have been
introduced to streamline drug licensing and testing
processes
Posted On: 27 MAR 2026 2:29PM by PIB Delhi
The New Drugs and Clinical Trials Rules, 2019 were amended vide G.S.R. 46(E) dated 20.01.2026
providing system of “prior intimation” instead of obtaining permission from Central Drugs Standard
Control Organization (CDSCO) for manufacture of certain categories of drugs (except certain high-risk
category of drugs) for analytical and non-clinical testing. This reform removes the existing requirement ofpharmaceutical companies to obtain a test licence for the manufacture of small quantities these dugs
intended for examination, research, or analysis purposes. This will reduce drug development timelines,
and there by promote innovation.
Ministry of Health and Family Welfare and CDSCO have taken following measures to ease the regulatory
landscape and fast-track approval for the manufacturing of drugs in the country:
(i) On 25.02.2026, CDSCO has issued a Guidance Document for submission of application for
obtaining Manufacturing License by the Applicant based on Dossier based licensing of Drugs. The
dossier-based approval process promotes the transparency and ensures fairness in the decision-making
process. The dossier-based approach is more efficient than the individual evaluation as it streamlines the
process and reduces the need for redundant assessment.
(ii) On 23.02.2026, CDSCO issued a circular to fast-track approvals for new drugs by allowing No-
Objection Certificates (NOCs) for laboratory testing to be issued immediately upon receipt of applications
a step aimed at reducing delays in the drug approval process. Under the revised procedure, NoCs for
testing new drugs at designated government laboratories shall be granted upfront, instead of waiting for
prior scrutiny of detailed technical specifications.
(iii) On 21.01.2026, the Central Government notified the replacement of permission system with online
intimation mechanism for BA/BE (bioequivalence/bioavailability) studies of unapproved drugs for export
purpose. It removes the prior permission requirements for carrying out low risk
bioavailability/bioequivalence studies for export purposes. By reducing regulatory timelines and
procedural requirements, this reform provides significant benefits to manufacturers and the generic
pharmaceutical industry.
(iv) On 02.01.2026, the Central government released the new Indian Pharmacopoeia (IP) 2026. Several
new blood products, vaccines and anti-tuberculosis medications have been included in it.
(v) Validity period for Free Sale Certificate issued by CDSCO to exporters, has been made co-terminus
with the validity of Manufacturing Licence.
(vi) In order to minimize the requirement of toxicity studies in animals, CDSCO published circular
dated 29.07.2024, to accept already generated preclinical toxicity data for review. Further, the requirement
of animal toxicity data needed in certain cases shall be determined on the case by case basis depending on
the nature of new claims as well as the mechanism of action etc. and non-clinical data already generated
with the drug in the approved claim.
(vii) In order to enable faster disposal of applications and licenses, CDSCO has issued orders for
delegation of powers of certain powers under the Drugs and Cosmetics Act, 1940 and rules thereunder to
officers of the rank of Joint Drugs Controller (India) and Deputy Drugs Controller (India).
(viii) Online National Drugs Licensing System (ONDLS) portal has been developed by Centre for
Development of Advanced Computing (CDAC) in coordination with CDSCO, Government of India and
State/UT Drugs Regulatory Authorities which is a single window platform for online processing of
various applications for manufacturing and sales licences. An online portal, SUGAM labs is in place since
September 2023 for integrating the drug testing labs of the CDSCO. It automates the entire workflow for
testing of Medical Products (Drugs, Vaccine, Cosmetics & Medical devices) to meet the quality
specification and tracing the testing status in the laboratories.
In order to assess the regulatory compliance of drug manufacturing premises in the country, the CDSCO
along with State Drugs Controllers (SDCs) have conducted Risk-Based Inspections of more than 960
premises since December, 2022 and based on findings, more than 860 actions like issuance of show causenotices, stop production order, suspension, cancellation of licenses /product licenses, warning letters have
been taken by the State Licensing Authorities.
Further, more than 1100 cough syrup manufacturers and 380 blood centres have been subjected to intense
audit in coordination with State authorities. Increased market surveillance sampling of syrup formulations
by Central and State drugs regulators has also been done.
To strengthen the drug testing infrastructure and enhance laboratory capacity across the country, Ministry
of Health and Family Welfare has implemented a Centrally Sponsored Scheme 'Strengthening of States’
Drug Regulatory System (SSDRS). The scheme envisages upgrading existing State laboratories, setting up
of new drug testing laboratories and upgradation of existing State drug control offices in the country.
Under the SSDRS Scheme, funds totalling Rs. 756 Crore has been released to States/UTs as part of the
Central Share and 19 New Drug Testing Labs have been constructed and 28 existing labs have been up-
graded in various States/UTs.
For post-market surveillance of approved drugs and medical devices, the National Coordination Centre
(NCC) for Pharmacovigilance Programme of India (PvPI) at Indian Pharmacopoeia Commission (IPC) at
Ghaziabad under the Ministry of Health and Family Welfare, Government of India is collecting the
adverse events reports related to the medical products from different Adverse Drug Reaction Monitoring
Centres of PvPI and other stakeholders across the country. These reports are analysed from time to time
and medical products safety related recommendations are sent to CDSCO for taking appropriate
regulatory actions.
The Union Minister of State for Health and Family Welfare, Smt. Anupriya Patel stated this in a written
reply in the Lok Sabha today.
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