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GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 4713
TOBE ANSWERED ON20TH MARCH, 2026
REGULATION ANDAPPROVALOFDRUGS
4713.SHRIKESINENI SIVANATH:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) the measures taken by the Government to ease the regulatory landscape for the
manufacturingof drugs inthe country;
(b) the numberof drug approval applications received by the Central Drugs Standard Control
Organisation along with the number of applications approved and currently pending during
the last five years, year-wise;
(c) the average time taken for granting drug approvals along with the measures taken by the
Government toexpeditethe approvalprocess andaddress delays;
(d) the measures taken by the Government to ensure regular and professional training of
officials of the Central Drugs Standard Control Organisation in order to enhance regulatory
expertise; and
(e) whether the Government has initiated any digitalization efforts to ensure timely grant of
drug approvalsandif so, the detailsthereof?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT. ANUPRIYAPATEL)
(a)to(e): Ministry of Health and Family Welfare and Central Drugs Standard Control
Organization (CDSCO) have taken following measures to ease the regulatory landscape for
the manufacturingof drugs inthe country;
(i) On 24.04.2025, the Central Government notified the Drugs and Cosmetics
(Compounding of Offences) Rules, 2025 creating a process of compounding of certain
minor offences under the Drugs and Cosmetics Act 1940. This serves to ease the
regulatory burden on the industry by providing a faster and non-adversarial alternative
to prosecution for eligible minor and technical offences, thereby saving time and costs
andenablingquickerclosure of such cases.
(ii) 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. Byreducing regulatory timelines and procedural requirements, this reform provides
significant benefitsto manufacturersandthe generic pharmaceutical industry.
(iii) The New Drugs and Clinical Trials Rules were amended vide G.S.R. 46(E) dated
20.01.2026 providing system of prior intimation instead of obtaining permission from
CDSCO for manufacture of certain categories of drugs for analytical and non-clinical
testing. This reform removes the existing requirement of pharmaceutical companies to
obtain a test licence for the manufacture of small quantities of certain categories drugs
intendedfor examination, research, or analysis purposes.
(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
beenincludedinit.
(v) Online Risk Classification Module for Medical Devices (including in-vitro diagnostics)
has been implemented on CDSCO’s Medical device (MD Online) Portal w.e.f.
27.11.2025. This New Risk Classification Module simplifies regulatory approval
procedures for medical devices and in-vitro diagnostics. It enables applicants to seek
online risk classification for devices not listed in the published classification list
reducingambiguityand ensures uniform applicationof Rules.
(vi) Increased the validity of Export NOC for certain drugs moving from consignment-
based Export NOC toOne yearNOC, andautomation of the process w.e.f.15.05.2025.
(vii) Validity period for Free Sale Certificate issued by CDSCO to exporters, has been made
co-terminuswith the validity of Manufacturing Licence.
(viii) 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 incertain 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 approvedclaim.
(ix) Provisions have been made for pre-submission and post-submission meetings of the
applicants with CDSCO for formal discussion and decision about case specific
regulatorypathway.
The number of applications received by the CDSCO, the number of applications
approved along with the number of applications under process inCDSCO during the last five
yearsisprovidedbelow:
Calendar No. of applications No. of applications No.of applications
Year received approved underprocess inCDSCO
2021 1038 729 8
2022 913 600 39
2023 791 366 59
2024 629 237 95
2025 696 95 221
*Certainapplications have beenwithdrawn, rejectedor are with the applicants for response.
CDSCO has undertaken extensive digitalization of regulatory processes through the
online portals such as cdscoonline.gov.in (SUGAM), cdscomdonline.gov.in (MedicalDevices), statedrugs.gov.in (ONDLS) and National Single Window System (NSWS).
Permissions/approvals for drugs are granted byCDSCO asper Drugs & Cosmetics Act, 1940
andRulesframedthereunderbased on eachcase through these portals.
In order to ensure regularandprofessional trainingof officials of the CDSCO and inorder
to enhance their regulatory expertise, a dedicated “Training Cell” division has been set-up at
CDSCO Head Quarter to impart training to both Central and State drugs regulatory officials.
CDSCO Training Cell has conducted 36 residential training programme at National Institute
of HealthandFamily Welfarefrom October 2022 toFebruary2026.
The training programmes cover a wide range of regulatory topics, including new
technologies, new therapies, emerging trends, Industry 4.0 technologies (AI, Robotics, Block
Chain& Automation), Good Distribution Practices (GDP), revised ScheduleM, Regenerative
Medicines and gene therapy and other relevant regulatory areas. Training is also imparted on
soft skills. In addition, trainings on WHO-GMP and ICH guidelines are conducted to
strengthen regulatory capacity and align officers with international standards. Further,
CDSCO also sends its officials on international trainings to upgrade theirinspection skills. In
addition,13 e-trainingmodules have beendevelopedfor regulatoryofficials.
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