While the Central Drugs Standard Control Organisation (CDSCO) is cracking down on erring industry actors, policy makers are pulling up government departments for slow implementation of schemes.
Thus India’s pharma industry, at least the MSME sector, is facing a tough transition to revised GMP norms, hampered by slow implementation of the very schemes that were intended to help them upgrade. This highlights gaps between policy intent and implementation, and the subsequent drag on compliance levels.
The Parliamentary Standing Committee on Chemicals and Fertilisers’ 34th Report presented in early August, pointed out that funds set aside under the Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS) for technological upgradation of eligible micro, small and medium pharma enterprises (MSMEs) was underutilised.
The report noted that even though almost the full allocation of Rs. 300.10 crore was approved, implementation was lagging.
In its reply, the DoP submitted that under the Scheme, 301 applications of pharma units for incentives aggregating to approximately Rs. 300.48 crore were approved, which is nearly equivalent to the total outlay of the sub-scheme, as on March 31, 2026.
Of the 301 approved applicants, claims of 64 pharma units amounting to Rs. 45.80 crore were approved, which is just over 20 per cent of the approved applicants. Of this, Rs. 41.70 crore has already been disbursed for 55 pharma units during FY 2025–26.
The DoP’s reply stated that the remaining 237 approved pharma units are at various stages, including claims under process, projects completed but yet to submit certificates and projects under implementation.
Given this delay of units going from approval to implementation, the Parliamentary Committee has recommended that the DoP should put in place urgent facilitation mechanisms and hand holding measures.
The RPTUAS was set up to help drug manufacturing units, specifically MSMEs, upgrade their facilities to meet Revised Schedule-M and WHO-GMP standards. Therefore delayed funds disbursement and implementation means that this segment of the sector will have patchy compliance until the upgradation.
The DoP’s submission is that the upgradation process in MSME pharma units, especially smaller units, tended to take longer as it disrupted normal operations.
It is but natural that smaller facilities tend to undertake upgrades in a phased manner over a period of time, while mid-sized firms can upgrade faster as they might have alternate facilities, so that production (and by that extension, revenue streams) are not completely disrupted or at a standstill.
The same report has also asked the DoP for an update on the bulk drug park promotion scheme, under which three bulk drug parks, (in Gujarat, Himachal Pradesh and Andhra Pradesh), were approved, with a grant-in-aid of `1000 crore to each park. Here too implementation is lagging. The panel has directed the DoP to submit a detailed status report on the ongoing progress of the three approved bulk drug parks and stressed tracking concrete measures taken to resolve ground-level execution hurdles and deadline slippages.
The Indian Pharmacopoeia Commission (IPC) is also reportedly setting up manufacturing guidelines for semaglutide, given the number of Indian pharma companies releasing generic copies of this complex molecule.
The fact that Dr Reddy’s Laboratories, one of India’s well respected pharma companies, stumbled on the generic semaglutide front is probably what triggered this inclusion in the forthcoming Indian Pharmacopoeia (IP) Addendum 2028.
DRL reportedly had to recall and pause commercial supplies of some batches of its generic semaglutide as an out-of-specification impurity was detected in the active pharmaceutical ingredient (API) during the production scale-up process.
While the CDSCO has given approval to certain Indian pharma companies to manufacture generic semaglutide for treating type 2 diabetes and managing weight, it has also specified that its use has to be linked to lifestyle changes and strictly under prescription.
CDSCO has also cracked down on illegal online sales, improper prescriptions, deceptive marketing and weight-loss claims, and influencer promotions. The agency has also conducted inspections of locations ranging from pharmacy warehouses, wholesalers, retailers, and slimming clinics, to curb misuse of weight-loss drugs. (https://www.expresspharma.in/midst-global-headwinds-cdsco-cracks-down-on-glp-1-gold-rush/)
Besides cracking down on manufacturing standards, the CDSCO has also turned its gaze on the clinical research segment. In late July, the CDSCO cancelled the registration certificates of seven ethics committees across India, flagging major compliance failures and serious regulatory deficiencies. This is a serious signal to India’s clinical research sector that enforcement of the New Drugs and Clinical Trial (NDCT) Rules 2019 and the amendments that followed will be strict.
While this is a tough transition period, it’s been long overdue. No doubt, there will be some smaller manufacturing units which will decide to call it a day, unable to muster up the funds, or the bandwidth and patience, to upgrade.
This is a necessary clean up of the sector, if we aim to compete to global norms. But these hard learnings will ensure better quality medicines for all. And that is the bottom line.