The Department of Pharmaceuticals has outlined a broad package of measures to expand access to affordable medicines, tighten price regulation and accelerate domestic manufacturing, signalling a sharper policy focus on lowering treatment costs while building long term capacity in the pharmaceutical and biopharma sectors.
In a series of written replies in the Lok Sabha on 20 March 2026, Minister of State for Chemicals and Fertilizers Anupriya Patel reported that the Pradhan Mantri Bhartiya Janaushadhi Pariyojana has scaled up to 18,646 Jan Aushadhi Kendras across the country as of 28 February 2026, with an official estimate of around ₹40,000 crore saved in out of pocket expenditure on medicines over the past 11 years through the use of low cost Janaushadhi products. Under the scheme, generic medicines are supplied at discounts of about 50 to 80 per cent compared to branded equivalents, and the government has set a target of expanding the network to 25,000 kendras by March 2027.
To support this expansion, Jan Aushadhi Kendra operators receive incentives equal to 10 per cent of their monthly purchases from the Pharmaceuticals and Medical Devices Bureau of India, capped at ₹10,000 per month, along with an additional incentive of up to ₹10,000 per month for maintaining stocks of 200 high demand medicines. A one time grant of ₹2 lakh is available for kendras in North Eastern states, Himalayan regions, island territories and aspirational districts, as well as for entrepreneurs from eligible groups including women, ex servicemen, persons with disabilities and members of Scheduled Castes and Scheduled Tribes. The ministry stressed that supplies to these outlets are sourced only from plants certified as compliant with WHO Good Manufacturing Practices, that every batch is tested before distribution and that quality checks are conducted exclusively in laboratories accredited by the National Accreditation Board for Testing and Calibration Laboratories and assessed for Good Laboratory Practices.
The government also highlighted the growing footprint and economic impact of Jan Aushadhi Kendras at the constituency and district level. In Sawai Madhopur Lok Sabha constituency of Rajasthan, 11 kendras are functional in Tonk district and 13 in Sawai Madhopur district, with sales at maximum retail price rising over the past three financial years to ₹0.20 crore and ₹0.66 crore respectively in 2024 25 and already at ₹0.18 crore and ₹0.62 crore in 2025 26 up to 28 February. In West Bengal, 894 kendras are operating under the scheme, including seven in Uttar Dinajpur district where one outlet functions in Hemtabad block, although no kendra is yet open in Chopra block and no application has been received from that area.
Officials said the government has adopted a franchise like model to attract individual entrepreneurs, non governmental organisations, trusts and private entities into the Janaushadhi network, with minimum qualification norms that require a pharmacist holding a D Pharma or B Pharma degree to obtain a drug licence from the state authority. To deepen uptake, the Pharmaceuticals and Medical Devices Bureau of India runs regular awareness campaigns across print, television, radio, social media, outdoor media and community programmes, backed by WhatsApp based messaging, outbound calls and the annual Jan Aushadhi Week of rallies, health camps and seminars. Outreach in rural areas is reinforced through street plays, Common Service Centre based audio visual material and public engagement workshops, while messages from prominent public representatives and doctors are used to underline the quality and savings associated with Janaushadhi medicines.
On pricing, the ministry underlined that the National Pharmaceutical Pricing Authority currently enforces ceiling prices on 935 scheduled formulations under the Drugs Prices Control Order 2013 and has fixed retail prices for 3,702 new drugs as defined in the order. Manufacturers of non scheduled medicines are barred from raising maximum retail prices by more than 10 per cent over any 12 month period, and the authority also invokes emergency powers under Paragraph 19 of the order in exceptional circumstances and public interest, a mechanism that has previously been used to cap prices of coronary stents, knee implants and selected anti cancer medicines and to regulate trade margins on several essential devices during the COVID 19 pandemic. Detailed price orders and revisions are made available on the NPPA website, and cases of overcharging are pursued through demand notices issued to companies to recover excess amounts with interest.
Between 2015 16 and 2025 26 up to 30 September 2025, NPPA issued 1,021 demand notices in overcharging cases, recovered around ₹13,860.93 lakh across 430 cases and has 591 cases currently pending, reflecting what the ministry described as an ongoing enforcement exercise without fixed time limits. To improve monitoring at the ground level, the government has set up Price Monitoring and Resource Units in states and union territories under the Consumer Awareness Publicity and Price Monitoring scheme, which track market prices and run public information campaigns. Consumers can lodge complaints and check prices through platforms such as the Pharma Jan Samadhan online system, the Pharma Sahi Daam mobile app that lists ceiling prices and the maximum retail prices of thousands of medicines, the CPGRAMS grievance portal, a dedicated helpline number and an official email contact.
Responding to concerns on the affordability of medicines and the balance between innovation and generics, the Department of Pharmaceuticals pointed to safeguards built into the Patents Act 1970. These include rigorous examination and two stage scrutiny of patent applications, broad pre grant and post grant opposition mechanisms to weed out non compliant patents and a specific bar on patenting new forms of known substances unless they demonstrate enhanced therapeutic efficacy, intended to prevent evergreening. Provisions for compulsory licensing can be invoked only when defined conditions such as lack of reasonable public access, failure to meet demand or non working of a patent in India are met, with the Controller of Patents empowered to set terms including reasonable royalties so that public interest is served without undermining legitimate commercial incentives for innovators.
On product quality and regulation of generics, the ministry conveyed that there is no separate legal definition of generic medicines in the Drugs and Cosmetics Act and Rules, and that the Central Drugs Standard Control Organization has not received reports of systemic variations in quality, therapeutic effectiveness or onset time between generic variants. All medicines, whether branded or generic and meant for domestic or export markets, must comply with the same statutory quality standards and are manufactured under a licensing and inspection regime run by state drug regulators. New drugs are cleared in line with the New Drugs and Clinical Trials Rules 2019 after expert evaluation of quality, safety and efficacy, with bio equivalence study results mandated for specified oral dosage forms to support efficacy claims.
To reinforce quality assurance after a series of high profile incidents worldwide, CDSCO and state regulators have stepped up risk based inspections of manufacturing premises, auditing more than 960 facilities since December 2022 and triggering over 860 regulatory actions including show cause notices, production stoppages, licence suspensions and cancellations, warning letters and other steps. More than 1,100 cough syrup manufacturers and 380 blood centres have undergone intensive audits, and advisories have been issued to state authorities to promote rational use of paediatric cough syrups, enforce testing requirements and maintain heightened vigilance against spurious and substandard medicines. The Indian Pharmacopoeia has also been amended to make testing for diethylene glycol and ethylene glycol mandatory at the finished product stage for oral liquids before release to the market.
Further measures include publication of periodic drug alerts listing products found to be not of standard quality, spurious, misbranded or adulterated, mandatory barcodes or QR codes on the primary or secondary packaging of the top 300 Schedule H2 formulations and on all active pharmaceutical ingredients to enable track and trace, and a comprehensive revision of Schedule M of the Drugs Rules on Good Manufacturing Practices. The revised manufacturing norms have been made applicable from June 2024 for companies with annual turnover above ₹250 crore and from January 2026 for smaller manufacturers. New guidelines for sampling by central and state drug inspectors have been introduced to standardise surveillance, while the SUGAM Labs online portal now integrates CDSCO drug testing laboratories to automate workflows and allow real time tracking of testing status, with coordination among state and central regulators strengthened through the Drugs Consultative Committee.
On the manufacturing front, the Ministry reported that the Production Linked Incentive scheme for pharmaceuticals, approved in 2021 to encourage high value drugs, complex generics and critical active pharmaceutical ingredients, has attracted cumulative investment of ₹41,943 crore by December 2025, far exceeding the committed target of ₹17,275 crore for the six year duration. The scheme has generated cumulative sales of ₹3,35,036 crore from 1,988 products, including exports worth ₹2,15,248 crore, and facilitated domestic production of 726 APIs, key starting materials and intermediates, 191 of which are being made in India for the first time, resulting in domestic sales of ₹28,067 crore and reduced import dependence.
A separate PLI scheme for bulk drugs, approved in 2020 to address supply risks from over dependence on single source imports, has seen investment of ₹4,814 crore in greenfield projects till December 2025 against a committed ₹4,329.95 crore. The programme has led to committed capacity of 91,077 metric tonnes per annum for 33 products and operational capacity of 56,800 metric tonnes per annum for 28 critical key starting materials, intermediates and active ingredients, with cumulative sales of ₹2,720 crore, including exports of ₹527.96 crore. Under this scheme, six new manufacturing units have been commissioned in Visakhapatnam district of Andhra Pradesh, which has been identified as an aspirational district, helping disperse industrial growth beyond traditional pharma clusters.
Budgetary support for these initiatives has been rising, with the PLI scheme for bulk drugs receiving ₹5.95 crore in 2022 23, ₹11.66 crore in 2023 24 and ₹21.30 crore in 2024 25, while disbursements under the pharmaceutical PLI scheme stood at ₹655.15 crore, ₹1,552.46 crore and ₹2,330 crore respectively over the same three financial years. Environmental compliance for bulk drug units is governed by the Environment Protection Act, the Water and Air Acts and associated regulations, under which these plants are classified as red category industries and must obtain environmental clearance as well as consent to establish and consent to operate before beginning production.
On the environmental dimension, information placed before Parliament showed that 24 red category pharmaceutical and chemical units currently operate in the union territory of Dadra and Nagar Haveli and Daman and Diu, all holding valid consolidated consent and authorisation, with no action required in the past five years on that specific count. However, some units have received notices in recent years for violations such as exceeding effluent and emission norms, non operation of effluent treatment plants and improper handling of hazardous waste, with two units flagged in 2022, one in 2023, one in 2024 and four in 2025. Zero liquid discharge requirements have not been made mandatory across all industries in the territory and no common effluent treatment plant functions there at present, so each industry must run its own effluent treatment facility and ensure recycling and reuse within its premises, though the territory is not listed among critically polluted areas by the Central Pollution Control Board.
Looking ahead, the Department of Pharmaceuticals is banking on the Biopharma SHAKTI scheme, which carries an outlay of ₹10,000 crore over five years, to deepen India’s capabilities in biologics and biosimilars and to support the availability of advanced therapies at affordable prices. The programme aims to build a globally competitive biopharma ecosystem spanning research, innovation and large scale manufacturing, with an explicit mandate to position India as a leading international hub in the segment while strengthening access to cutting edge treatments across all states and union territories, including Andhra Pradesh.
