Minister of State for Road Transport and Highways, Shipping and Chemicals and Fertilizers, Shri Mansukh L. Mandaviya, while giving a written reply to a question on quality of generic medicines, in Lok Sabha today, stated that isolated complaints regarding suspected quality of medicines have been received. As and when such complaints are received, based on the merit, the matter is taken up by Central Drugs Standard Control Organization (CDSCO) in coordination with concerned State Licensing Authority for action as per theprovisions of Drugs & Cosmetics Act, 1940 and the Drugs & Cosmetics Rules, 1945.
The Government of India has taken various measures to ensure quality of drugs including generic drugs manufactured/ marketed in the country. Details are as under;
The Drugs and Cosmetics Act, 1940 was amended under Drugs & Cosmetics (Amendment) Act 2008 to provide stringent penalties for manufacture of spurious and adulterated drugs. Certain offences have also been made cognizable and non-bailable.
The States / UTs were requested to set up Special Courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal. So far, 22 States have already set up designated special Courts.
Guidelines for taking action on samples of drugs declared spurious or not of standard quality in the light of enhanced penalties under the Drugs & Cosmetics (Amendment) Act, 2008 were forwarded to the State Drugs Controllers for uniform implementation.
The number of sanctioned posts in Central Drugs Standard Control Organization (CDSCO) has been increased from 111 in 2008 to 510 in 2018.
The testing capacities of Central Drugs Testing Laboratories under CDSCO are being constantly strengthened to expedite testing of drug samples in the country.
On 03.04.2017, in order to ensure efficacy of drugs, the Drugs and Cosmetics Rules, 1945 have been amended providing that applicant shall submit the result of bioequivalence study along with the application for grant of manufacturing licence of oral dosage form of drugs falling under the Category II and Category IV of the Biopharmaceutical Classification System.
On 10.04.2018, the Drugs and Cosmetics Rules, 1945 have been amended vide Gazette notification no. G.S.R. 360 (E), making it mandatory for all drugs, that the applicants shall submit evidence of stability, safety of excipients etc. to the State Licensing Authority before grant of product manufacturing license by the Authority.
Draft Rules have been published vide GSR 999 (E), dated 05.10.2018 to amend the Schedule M of the Drugs and Cosmetics Rules, 1945 to make it more comprehensive at par with the WHO-GMP guidelines
On 27.10.2017, the Drugs and Cosmetics Rules, 1945 have been amended vide Gazette notification no. G.S.R. 1337 (E) making it mandatory that before the grant of manufacturing license, the manufacturing establishment is to be inspected jointly by the Drugs Inspectors of Central Government and State Government.
The licensed manufacturing premises shall be inspected jointly by the Drugs Inspectors of Central Government and State Government to verify the compliance with the conditions of license and the provisions of the Drugs & Cosmetics Act and Rules for not less than once in three years or as needed as per risk based approach.
The Government has decided to strengthen both the Central and States drug regulatory system during the 12th Five Year Plan enabling them to keep more effective watch on unscrupulous elements indulging in unlawful activities relating to quality of drugs. The Cabinet Committee on Economic Affairs (CCEA) has approved the proposal for strengthening the drug regulatory system in the country, both under the Central and State Governments at a total expenditure of Rs. 1750 crores. Out of this, Rs. 850 crore is the Central Government’s share. The share of the Centre and the States in case of state component will be in the ratio of 60:40 for all States except Jammu and Kashmir, Himachal Pradesh, Uttarakand, Sikkim and North-Eastern States, for which the ratio will be 90:10.
Minister of State for Road Transport and Highways, Shipping and Chemicals and Fertilizers, Shri Mansukh L. Mandaviya, while giving a written reply to a question in Lok Sabha today,detailed the following steps taken by Government to promote the use of domestically manufactured drugs and medicines:
National Pharmaceuticals Pricing Policy, 2012 (NPPP-2012) was notified with the objective to put in place a regulatory framework for pricing of drugs so as to ensure availability of required medicines – “essential medicines” at reasonable prices even while providing sufficient opportunity for innovation and competition to support the growth of pharma industry thereby meeting the goals of employment and shared economic well-being for all.
In order to promote and to make available quality generic medicines at affordable prices to all through specific outlets, a scheme in the name of ‘Pradhan Mantri Bhartiya Janaushadhi Pariyojana’ (PMBJP) is functioning across the country.
In order to promote domestically manufactured drugs, the Government is providing financial support for research and development through Drugs & Pharmaceuticals Research Programme (DPRP) run by the Department of Science & Technology. The companies undertaking Research & Development activities are provided income tax benefits.
The Drugs (Prices Control) Order, 2013, Para-32(iii) provides exemptions from price control to a manufacturer producing a new drug involving a new delivery system developed through indigenous Research and Development for a period of five years from the date of its market approval in India.
The government vide its notification dated 28th January, 2016 has withdrawn exemption of customs duty on certain categories on Bulk Drugs/APIs to provide level playing field to the domestic manufacturers.
The Minister further said that in order to make generic medicines more accessible, the Department of Pharmaceuticals has requested all the States/Union Territories to explore and enforce the proposal of keeping a separate shelf/rack for generic medicines in every pharmacy in the country.
Further, Government is successfully operating a scheme in the name of ‘Pradhan Mantri Bhartiya Janaushadhi Pariyojana’ (PMBJP) for providing quality, unbranded generic medicines at affordable prices in the country. Under this Scheme dedicated outlets known as Pradhan Mantri Bhartiya Janaushadhi Kendra (PMBJK) are opened to provide generic medicines. As on 13.12.2018, 4,571 PMBJKs have been opened across the country. Under PMBJP Scheme a target has been set to open at least one PMBJP Kendra in every district of the country, Shri Mandaviya stated.
Minister of State for Road Transport and Highways, Shipping and Chemicals and Fertilizers, Shri Mansukh L. Mandaviya, while giving a written reply to a question on Government’sinitiative of ensuring affordable, quality medicines for all, in Lok Sabha today, stated that ceiling prices of 856 medicines have been fixed by the National Pharmaceutical Pricing Authority (NPPA), resulting in a saving of Rs. 11,462 crore for patients (as on 30th November 2018).
Shri Mandaviya also said that after fixing the ceiling price of coronary stents,NPPA has been closely watching their availability in the country andno shortage has been reported so far in this regard.At present, prices have been fixed by NPPA for 856 formulations, including 4 medical devices, which are covered under Schedule–I of the DPCO, 2013.
As per Paragraph 20 of the DPCO 2013, NPPA monitors the Maximum Retail Prices (MRPs) of all drugs, including the non-scheduled formulations and ensures that no manufacturer increases the maximum retail price of a drug more than ten percent of maximum retail price in preceding twelve months. NPPA is effectively monitoring the prices of medicines including the non-scheduled formulations and takes action against companies found overcharging.
The Department of Pharmaceuticals has also launched a Scheme ‘Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP)’ in order to make quality generic medicines at affordable prices to all through specific outlets. As on date, 4571 PMBJP outlets are functional across the country, Shri Mandaviya stated.