Year 2017 Review : DEPARTMENT OF PHARMACEUTICALS
1.) PRADHAN MANTRI BHARTIYA JANAUSHADHI PARIYOJANA (PMBJP)
· During the period from 1.1.17 to 18.12.2017, 3019 PMBJP Kendras are functional. The scheme’s product basket has been expanded to cover 652 medicines and 154 surgicals & consumables covering all therapeutic categories such as Anti-infectives, Anti-diabetics, Cardiovasculars, Anti-cancers, Gastro-intestinal medicines, etc.
· Several MoUs have been signed with various State Government/Organisations/NGOs to promote opening of PMBJKs across the country. As on 2nd November, 2017, 36,564 applications have been received from private individuals, out of which in-principle approval has been given in all the applications.
· Department of Pharmaceuticals persuaded the Medical Council of India (MCI) to issue guidelines to Health Secretaries of all the States/ UTs and President of all the State Medical Councils to comply with the ethics regulation of para 1.5 Use of generic names of drugs under IMC Act.
2.) CAPPING OF CEILING PRICES OF STENTS AND KNEE IMPLANTS:
· The ceiling price of the Coronary Stents, was revised with effect from 1st April, 2017. All types of cardiac stents are now available in the price range of Rs. 7,400 to Rs.30, 180.
· Knee Implant ceiling prices are fixed with effect from 16th August, 2017. Various types of knee implants are now available in the price range of Rs. 54,720 to 1,13,950.
· The Reduction in Prices of coronary stents was up to 85% and that for knee implants was up to 69% of the prices before price cap.
· Total estimated saving of Rs. 5,950 crores to general public: The capping of prices of Coronary Stents resulted into estimated savings of Rs. 4450 crores and that of Knee Implants into estimated savings of Rs. 1500 crores.
3.) NPPA has fixed the ceiling prices of 255 formulations during January, 2017 to November, 2017, resulting in total formulations under price control to 849 under NLEM 2015. The fixation of ceiling price of scheduled formulations resulted in saving of Rs. 2643.37 crore to consumers.
During January, 2017 to November, 2017, an amount of Rs. 179.45 crore was recovered from pharmaceutical companies for overcharging and 226 demand notices (including suo motu cases) were issued for overcharging amounting to Rs. 728.99 crore during the said period.
4.)Pharma Data Bank provides a platform to the Pharmaceutical Manufacturer/ Marketing/ Importer/ Distributor Companies to file mandatory returns prescribed in Form II, Form III and Form V of Drugs (Prices Control) Order,2013 (DPCO, 2013) and applications for price approval of ‘new drug’ under DPCO,2013 too online. As on 11.12.2017, 862 companies are registered for 64804 products. Out of 862 companies registered, Form V compliance status of 121 companies is 100% in respect of products registered by them.
5.) Mobile Apps/ other tools: NPPA has recently launched its mobile app on 29.08.2016 named as Pharma SAHI DAAM for the benefit of the common people of India through which anybody can easily search the brand name, composition, ceiling price and MRP of the formulation. This app can be downloaded from Google play store free of cost for Android based mobile phones and from Appstore for IOS based mobile Phone (iphone). Ceiling Price of scheduled formulations may also be obtained by using the tool ‘Search Medicine Price’ available in the website of NPPA.
6.) Monitoring and Enforcement: Based on the analysis of data provided by AIOCD PharmaTrac, NPPA identified 336 formulations as without price approval cases.
7.) Department has prepared an Umbrella Scheme namely ‘Scheme for Development of Pharma Industry’ comprising of
a. Assistance to Bulk Drug Industry for Common Facilitation Centre.
b. Assistance to Medical Device Industry for Common Facilitation Centre.
c. Assistance to Pharmaceutical Industry
d. Pharmaceutical Technology Upgradation Assistance Scheme
e. Pharmaceutical Promotion and Development Scheme.
EFC Memo for the Umbrella Scheme has been circulated to the concerned Ministries/ departments for comments.
8.) PHARMACEUTICALS PROMOTION & DEVELOPMENT SCHEME (PPDS)
· Launched in 2008 (Since the formation of Department of Pharmaceutical), with the objective of promotion, development and export promotion in Pharmaceutical sector by extending financial support for conduct of seminars, conferences, exhibitions, mounting delegations to and from India for promotion of exports as well as investments, conducting studies/consultancies, for facilitating growth, exports as well as critical issues affecting Pharma sector.
· Financial assistance given to total number of 17 Events/ Seminars till 2nd Nov., 2017
· 2nd edition of India Pharma and India Medical Device – International Exhibitions & Conferences on Pharmaceuticals and Medical Devices sectors – organized at Bengaluru, Karnataka from 11-13th February, 2017. 275 exhibitors from Pharma and Medical Device sectors and hosted Buyers from 24 countries. International Drug Regulators from 8 countries, 29 officials from foreign Embassies/High Commissions in India apart from 10,000 Business Visitors visited during the event.
9.) National Pharmaceutical policy is under consideration so as to cover the entire gambit of the pharma sector.
10.) After reviewing the implementation of Uniform Code for Pharmaceuticals Marketing Practices (UCPMP), the Department is in the process of consultation with the Ministry of Law and Justice for making a statutory order for controlling the unethical practices being adopted by some Pharmaceutical companies.
11.) The Department has constituted a Committee of Joint Secretaries having representatives from NPPA, Health, DIPP, DCGI to review Drug Price Control Order(DPCO), 2013 for ensuring enhanced accessibility of drugs to the poor. The Committee has since submitted its recommendations. Amendments to the provisions of DPCO, 2013 are being considered on the basis of the recommendations and discussions with the stakeholders.
12.) National Institute of Pharmaceutical Education and Research (NIPER): Following the announcement of the Government for setting up of NIPERs one each in Chhattisgarh, Maharashtra and Rajasthan, State Governments of Rajasthan, Chhattisgarh and Maharashtra have agreed to provide land at Jhalawar, Raipur and Nagpur respectively for opening of NIPERs.
7 NIPERs have undertaken Academia-Industry linkage with 17 leading Pharma Industries through 24 MOUs. Institutional mechanism on NIPER-Industry partnership for campus placements and CEO talks has also been established. During the academic year 2017-18, 596 students are pursuing Master’s degree courses and 72 students are pursuing PhD courses in various NIPERs.
13.) Cabinet Committee on Economic Affairs (CCEA) in its meeting held on 1.11.2017 accorded ‘in principle’ approval for strategic disinvestment of Karnataka Antibiotics and Pharmaceuticals Ltd, a PSU under Department of Pharmaceuticals.