Parliament Question: Ayush Formulations in PMBJP

GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS LOK SABHA UNSTARRED QUESTION No. 5588 TO BE ANSWERED ON THE 27TH MARCH 2026 Ayush Formulations in PMBJP 5588. Shri Brijmohan Agrawal: Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state: (a) the total number of Ayush formulations currently included in the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) product basket and the steps taken to expand the said range; (b) whether the Ministry has established specific quality control and standardization criteria for small-scale Ayush manufacturers to facilitate their participation in the PMBJP procurement process, if so, the details thereof; (c) the measures being taken to address regional disparities in the availability of generic Ayush medicines, particularly in forest-rich and tribal-dominated States like Chhattisgarh; (d) whether there is a proposal to synchronize the National Essential Medicines List for Ayush with the PMBJP procurement cycle to ensure a steady supply of classical formulations, if so, the details thereof; (e) the details of the monitoring mechanism to track the price difference and savings provided to citizens through generic Ayush products compared to branded alternatives; and (f) the total number of PMBJP kendras in country and also share detailed list for Chhattisgarh? ANSWER THE MINISTER OF STATE IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SMT. ANUPRIYA PATEL) (a): Under Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) Scheme, 5 Ayurvedic products have been added in the product basket, which are being made available through selected Jan Aushadhi Kendras (JAKs) at affordable rates. The products are Chyawanprash Special 500 gm, Chyawanprash Special 1000 gm, Triphala, Shilajit and Ashwagandha. The product basket has been reviewed from time to time by a committee to evaluate the market demand of existing and newly launched/off-patent medicines, based on feedback and analysis from JAKs, citizens and market reports. (b): With a view to ensure quality of medicines including Ayurvedic products available at JAKs so that health of patients is not compromised, concrete mechanisms have been put in place to ensure continuous inspection, testing and standardisation, including the following:(i) Supply only from WHO Good Manufacturing Practices (GMP) certified plants: Only plants that are certified as WHO-GMP compliant by the Central Drugs Standard Control Organisation (CDSCO) after direct inspection are eligible for supply. (ii) Distribution only after 100% pre-testing of all medicine batches: Samples are drawn from 100% of batches supplied at PMBI’s warehouses for testing anonymously, and medicines are dispatched for supply to JAKs only after the quality test is passed. (iii) Testing only at labs compliant with Good Laboratory Practices (GLP): Samples are tested only at labs accredited and periodically inspected by the National Accreditation Board for Testing and Calibration Laboratories (NABL) and, in addition, assessed by PMBI for GLP compliance. Ministry of Ayush has informed that following steps have been taken by the Government for quality control and standardization criteria for small-scale Ayush manufacturers:- • The Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945 have exclusive regulatory provisions for Ayurveda, Siddha, Sowa-Rigpa, Unani, and Homoeopathy drugs. Provisions related to Ayurveda, Siddha, Sowa-Rigpa, Unani Drugs are contained in Chapter IVA and Schedule- I of the Drugs and Cosmetics Act, 1940 and Rules 151 to 169, Schedules E(I), T & TA of the Drugs Rules, 1945. Further, second schedule (4A) of the Drugs and Cosmetics Act, 1940 provides standards for Homoeopathic drugs and Rules 2dd, 30AA, 67 (C-H), 85 (A to I), 106-A, Schedule K, Schedule M-I of the Drugs Rules, 1945 pertain to Homoeopathic drugs. It is mandatory for the manufacturers to adhere to the prescribed requirements for licensing of manufacturing units & medicines including proof of safety & effectiveness, compliance with the Good Manufacturing Practices (GMP) as per Schedule T & Schedule M-I of Drugs Rules, 1945 and quality standards of drugs given in the respective pharmacopoeia. • Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), sub- ordinate organization under Ministry of Ayush, lays down the formulary specifications and pharmacopoeial standards for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs which serves as official compendia for ascertaining the quality (identity, purity and strength) of the ASU&H drugs. As per the Drugs & Cosmetics Act, 1940 and rules there under, the compliance to this quality standards are mandatory for manufacturing of ASU&H drugs. • PCIM&H also acts as the Appellate Drugs testing Laboratory for testing or analysis of ASU&H Drugs. In addition, it conducts capacity-building trainings at regular intervals for the standardization, quality control, and testing or analysis of ASU&H drugs for Drug Regulatory Authorities, Drug Analysts, and other relevant stakeholders, with a focus on laboratory techniques and methodologies essential for ensuring the quality of ASU&H drugs. • Rule 160 A to J of the Drugs Rules, 1945 provides the regulatory guidelines for approval of Drug Testing Laboratory for carrying out such tests of identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs as may be required under the provisions of these rules, on behalf of licensee for manufacture of Ayurvedic, Siddha and Unani drugs. As on date, 34 State Drug Testing Laboratories have beensupported for strengthening their infrastructural and functional capacity. Further, 108 laboratories are approved or licensed under the provisions of Drugs Rules, 1945 for quality testing of Ayurvedic, Siddha and Unani drugs and raw materials. • Ministry of Ayush has established an Ayush vertical in the Central Drugs Standard Control Organisation (CDSCO), which includes the posts of 1 Deputy Drugs Controller, 4 Assistant Drugs Controllers, and 4 Drug Inspectors. Drug Inspectors posted in Ayush vertical, inspect various manufacturing units in coordination with the licensing authorities/drug inspectors of the respective States/Union Territories for ensuring safety and quality of Ayush medicines. • Ministry of Ayush is implementing a Central Sector Scheme “Ayush Oushadhi Gunavatta evam Uttpadan Samvardhan Yojana” (AOGUSY) since 2021-22 with total budget outlay of Rs. 122.00 crores for five years. The scheme has inter alia one of the component to strengthen and up-grade the Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards like WHO-GMP and NABL respectively. (c): With a view to ensure accessibility and availability of affordable medicines at Jan Aushadhi Kendras across the country including State of Chhattisgarh, the following measures are in place: i. An end-to-end information-technology-enabled supply chain system consisting currently of five warehouses and 41 distributors across the country, is in place. ii. Since September 2024, stocking by Jan Aushadhi Kendras (JAKs) of 200 commonly used medicines, consisting of the 100 top-selling medicines in the product basket and 100 fast-selling medicines in the market, is incentivised with JAK owners being eligible to receive monthly incentive based on the stocks that they maintain of these medicines. iii. In addition, with a view to ensure availability of commonly used products, 400 fast- moving products are monitored regularly by the scheme implementing agency {Pharmaceuticals and Medical Devices Bureau of India (PMBI)} and demand for the same is forecasted on an ongoing basis. Further, steps have been taken to digitise the forecasting method to augment the procurement process through automation. M/o Ayush has informed that National Ayush mission inter alia make provision for supply of essential Ayush drugs in Ayush hospitals and dispensaries in states and UTs. (d): As per information provided by Ministry of Ayush, to ensure safe, effective, and accessible care, a consolidated list of essential formulations was developed in line with WHO policy, leading to the publication of the Essential Drug List (EDL) of ASU&H. With evolving disease patterns and public health needs, the list was revised into the National List of Essential Ayush Medicines (NLEAM), based on criteria such as availability, usage, evidence, safety, and cost-effectiveness, through extensive stakeholder consultation. This harmonized list supports rational selection, procurement, and supply of quality medicines across all levels of healthcare, helps to prevent shortages, promotes cost-effective resource use, and serves as a reference for both public and private sectors, while also encouraging research and revalidation of classical formulations. (e): The Government launched the Pradhan Mantri Bhartiya Janaushadhi Pariyojana scheme to make quality generic medicines available at affordable prices to all. Under the scheme,dedicated outlets known as Jan Aushadhi Kendras are opened across the country to provide medicines including ayurvedic product available under PMBJP product basket at rates that are about 50% to 80% cheaper than those of branded medicines. During the past 11 years, total savings of ₹ 40,000 crores by way of reduced “Out-of-Pocket Expenditure” on medicines on account of use of Janaushadhi Products including Ayurvedic products. (f): Under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana scheme, a total of 18,646 Jan Aushadhi Kendras are opened across the country as on 28.02.2026, of which 352 JAKs are opened in the State of Chhattisgarh. The district-wise list of JAKs opened is enclosed as Annexure.Annexure Annexure referred to in the reply to part (f) of the LOK SABHA UNSTARRED Q. No. 5588 for answer on 27.03.2026, raised by Shri Brijmohan Agrawal regarding Ayush Formulations in PMBJP District-wise number of JAKs opened in the State of Chhattisgarh as on 28.02.2026 Sl. No. District Name Number of Kendras 1 Bastar 11 2 Bilaspur 20 3 Dakshin Bastar Dantewada 2 4 Dhamtari 10 5 Durg 61 6 Janjgir-Champa 10 7 Jashpur 9 8 Uttar Bastar Kanker 4 9 Kabirdham 7 10 Korba 12 11 Koriya 3 12 Mahasamund 11 13 Raigarh 12 14 Raipur 42 15 Rajnandgaon 19 16 Surguja 5 17 Bijapur 3 18 Narayanpur 3 19 Sukma 1 20 Kondagaon 7 21 Balodabazar-Bhatapara 22 22 Gariyaband 7 23 Balod 8 24 Mungeli 8 25 Surajpur 7 26 Balrampur-Ramanujganj 7 27 Bemetara 10 28 Gaurela-Pendra-Marwahi 5 29 Khairagarh-Chhuikhadan-Gandai 7 30 Manendragarh-Chirmiri-Bharatpur(M C B) 6 31 Mohla-Manpur-Ambagarh Chowki 4 32 Sakti 5 33 Sarangarh-Bilaigarh 4 Total 352 *******