कथन

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state: 12.12.2025 253 (a) the steps taken/proposed to be taken by the Government to ensure greater affordability and accessibility of low-risk self-care medical devices for citizens; (b) whether the Government proposes to streamline or ease the MD-42 registration requirements for low-risk self-care medical devices, particularly in view of the rapidly growing manufacturing clusters such as Baddi, Nalagarh, Sansarpur Terrace and other regions of Himachal Pradesh and if so, the details thereof; (c) whether the Government has taken any measures to eliminate the fragmented compliance system and introduce a "One Nation, One Licence" framework for low- risk medical devices to support ease of doing business and faster citizen access and if so, the details thereof, State wise; and (d) the steps taken/proposed to be taken by the Government to introduce a more risk proportionate and differentiated regulatory framework for Class A and Class B medical devices, distinct from the more stringent requirements for Class C and D devices, keeping in view India’s expanding domestic manufacturing capacity? THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE; AND MINISTER OF STATE IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SHRIMATI ANUPRIYA PATEL): (a): As per the information provided by Department of Pharmaceuticals (DoP), the National Pharmaceutical Pricing Authority (NPPA) under DoP fixes the ceiling price of medicines included in the National List of Essential Medicines (NLEM) issued by the Ministry of Health and Family Welfare and incorporated in Schedule-I to Drugs (Prices 12.12.2025 254 Control) Order, 2013 (DPCO, 2013). NPPA also fixes the retail prices of new drugs as defined under DPCO, 2013. In addition, for the non-scheduled drugs, DPCO, 2013 provides that no manufacture shall increase the maximum retail price (MRP) of such drugs by more than 10 per cent of their MRP in the preceding 12 months. Four medical devices i.e Bare metal stents, drug eluting stents, condoms and intra uterine devices are included in the NLEM, 2022 and hence notified under Schedule-I and their ceiling prices have been fixed by NPPA. Also, NPPA has fixed the ceiling price for Orthopedic Knee Implants in the year 2017 and capped the trade margin of oxygen concentrators, pulse oximeter, blood pressure monitoring machine, nebuliser, digital thermometer and glucometer during June/July 2021, in public interest. NPPA vide SO. 1232(E) dated 31.03.2020 notified that all medical devices shall be governed under the provisions of DPCO, 2013 w.e.f 01.04.2020. Accordingly, manufacturers of non-scheduled medical devices required not to increase the MRP of such devices by more than 10% of the MRP during period of the preceding 12 months. (b) to (d): Under the Medical Device Rules, 2017, import of all classes of Medical Devices (Class A, B, C and D) as well as manufacture of Class C and D Medical Devices are regulated by Central Drugs Standard Control Organization (CDSCO), while manufacture of Class A and B Medical devices is regulated by the concerned State Licensing Authorities (SLA) appointed by the State Governments. 12.12.2025 255 Under the said rules, in order to simplify the process, separate provisions for registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device has been introduced through Form MD-41 (application) and Form MD-42 (Registration certificate). Also the requirement for prior inspection of the premises for grant of registration certificate is exempted, requirement of educational qualification and experience is simplified and the decision regarding registration certificate is taken within the time period of 10 days by the State Licensing Authority. Besides, low-risk Class A (non-sterile, non-measuring) devices are permitted through a self-certification and online registration process without any mandatory pre- or post-licence inspection. Further, for uniformity and transparency, a common portal for States/UT viz www.cdscomdonline.com. has been made operational. MEDICINAL PLANT SPECIES IN GANDHAMARDAN MOUNTAIN RANGE 2113. SHRI PRADEEP PUROHIT: Will the Minister of AYUSH be pleased to state: (a) the details of medicinal plan species found in the Gandhamardan mountain range in the Bargarh district of Odisha as per the Botanical Survey of India; (b) whether it is a fact that the Ayurvedic College located at Nrusinghnath in the Gandhamardan region has been playing a vital role in the study and research of these medicinal plants and if so, the details thereof; 12.12.2025 256 (c) whether there is any proposal to take over this Ayurvedic College under the Central Government; and (d) if so, the details thereof and if not, the reasons therefor? THE MINISTER OF STATE OF THE MINISTRY OF AYUSH; AND MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI PRATAPRAO GANPATRAO JADHAV): (a): As per the recent field tour conducted by the Botanical Survey of India (BSI) and Odisha State Biodiversity Board, about 406 plant species observed in the Gandhamardan mountain range in the Bargarh district of Odisha. However, as per the information received from the BSI, during the year 2009, a total 912 plant species were found in the Gandhamardhan Hills of Bargarh, Odisha, out of which 345 species were classified as medicinal plants. (b): No such details are available with the Ministry of Ayush regarding playing a vital role in research work of these medicinal plants by Ayurvedic College located at Nrusinghnath in the Gandhamardan region. (c): Currently, the Government has no such proposal under consideration. (d): Does not arise. SALE OF ANTI-DEPRESSANTS 2114. SHRI SRIBHARAT MATHUKUMILLI: Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state: 12.12.2025 257 (a) whether the Government maintains data on the number of anti-depressant drugs sold in the country during the last five years and if so, the details thereof, year- wise and State/UT-wise; (b) the details of anti-depressant drugs currently approved, available and marketed in the country; (c) whether the Government is aware that anti-depressants are being prescribed for off-label uses in the country and if so, the details thereof; (d) whether the Government has put in place safeguards and regulatory measures to prevent misuse or inappropriate prescription of anti-depressants for off-label indications and if so, the details thereof; and (e) the current status of the draft rules on the regulation of sale and distribution of drugs through e-pharmacy platforms, first notified in 2018? THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE; AND MINISTER OF STATE IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SHRIMATI ANUPRIYA PATEL): (a) to (d): Sale of drugs in the country is regulated under the provisions of Drugs and Cosmetics Act, 1940 and the Rules made thereunder, by the State Governments through a system of licensing and inspection. State Licensing Authorities (SLAs) are legally empowered to take action against violation of provisions of the said Act and Rules. Data related to the sale of anti-depressant drugs in the State/UTs is not maintained centrally. 12.12.2025 258 During the last three years, Central Drugs Standard Control Organisation (CDSCO) has approved seven anti-depressant drug products for use in country. Drugs, including anti-depressants, are approved along with their indication(s), dosage form, route of administration, and strength in accordance with the regulatory framework. Various notices/Advisories/Letters have been issued to all State Drugs Controllers, other stakeholders for strict compliance of the requirements of Drugs and Cosmetics Act and Rules made thereunder and for raising awareness in the public regarding adverse effects of misuse of drugs. (e): In order to comprehensively regulate online sale of medicines, the Government of India has published draft rules vide its notification dated 28.8.2018, inviting comments from public and stakeholders on amendments to the Drugs Rules, 1945 for incorporating provisions relating to regulation of sale and distribution of drugs through e-pharmacy. The draft rules contain provisions for registration of e-pharmacy, periodic inspection of e-pharmacy, procedure for distribution or sale of drugs through e- pharmacy, prohibition of advertisement of drugs through e-pharmacy, complaint redressal mechanism, monitoring of e-pharmacy, etc. DELAY IN DISPOSAL OF EXECUTION PETITIONS 2115. SUSHRI PRANITI SUSHILKUMAR SHINDE: 12.12.2025 259

वक्ता Jagdambika Pal

कब कहा 2025-12-12T00:00:00.000Z

किस वाद-विवाद में Regarding expansion and development of Mohammadabad Air strip in Farrukhabad into a full fledged Airport