Lok Sabha Question No. 1820 (UNSTARRED), answered on 2018-07-27
Subject: Prescribing of Generic Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: MD. BADARIDDOZA KHAN, MUTHAMSETTI SRINIVASA RAO (AVNTHI), MOHAMMAD SALIM, SUMEDHANAND SARASWATI, OM PRAKASH YADAV, SANTOSH AHLAWAT

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

LOK SABHA UNSTARRED QUESTION NO. 1820 th

TO BE ANSWERED ON 27 JULY, 2018

## PRESCRIBING OF GENERIC DRUGS

## 1820. SHRI MD. BADARUDDOZA KHAN:

SHRI MUTHAMSETTI SRINIVASA RAO(AVANTHI):

SHRI MOHD. SALIM:

SHRI SUMEDHANAND SARSWATI:

SHRI OM PRAKASH YADAV:

SHRIMATI SANTOSH AHLAWAT:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) whether Government is making it mandatory for doctors to prescribe generic medicines and if so, the details thereof;
- (b)  whether  the  Government  has received  any  complaints  in  which  doctors have  refused  to prescribe generic medicine to the patient and if so, the details thereof along with action taken thereon;
- (c) whether doctors are reluctant to prescribe generic drugs for want of quality assurance and if so, the steps taken to assure the quality of generic drugs;
- (d)  whether  some  of  the  doctors' community  are  against  this  regulation,  if s ,  the  reasons therefor; and
- (e) whether the Government is also contemplating to bring a law requiring doctors to prescribe generic drugs and if so, the details thereof and the time by which the said law is likely to be enacted?

## ANSWER THE MINISTER OF STATE IN THE MINIS TRY OF HEALTH AND FAMILY WELFARE

(SHRI ASHWINI KUMAR CHOUBEY)

(a) to (e): The professional conduct of doctors in India is regulated by the Medical Cou of India (MCI) and the respective State Medical Councils in accordance with the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 . Clause 1.5 of the said regulations prescribes that every physician should prescribe drugs with generic names legib and preferably in capital letters and he/she shall ensure that ther e is a rational prescription and use of drugs .

Further, Manufacturing, sale and distribution of drugs in the country are regulated the provisions of Drugs & Cosmetics Act, 1940 and Rules made thereunder through a system licensing and inspection. License for manufacturing, sale and distribution of drugs are granted State Licensing Authorities appointed by respective State Governments. Drug manufactured the country, irrespective of whether branded or generic, are required to comply with th ame standards  as  prescribed  in  the  said  Act  and  Rules  for  their  quality.  The  State  Li Authorities are empowered to take action against violations of any of the above requiremen

CDSCO under the Ministry of Health and Family Welfare has taken various measures to ensure the quality of generic medicines in the country which include:

- I. The  Drugs  and  Cosmetics  Act,  1940  was  amended  under  Drugs  &  Cosmetics (Amendment) Act 2008 to provide stringent penalties for manufacture of spurious a adulterated drugs. Certain offences have also been made cognizable and non - bailable.
- II. The States / UTs were requested to set up special Courts for trial of offences un Drugs  and  Cosmetics  Act  for  speedy  disposal.  So  far,  22  States  have  already  se designated special Courts.
- III. Guidelines for taking action on samples of drugs declared spurious or not of sta quality in the light of enhanced penalties under the Drugs & Cosmetics (Amendmen Act, 2008 were forwarded to the State Drugs Controllers for uniform i mplementation.
- IV. The inspectorate staffs have been instructed to keep a vigil and draw samples of dr test and analysis to monitor the quality of drugs moving in the country.
- V. The  number  of  sanctioned  posts  in  Central  Drugs  Standard  Control  Organizat ion (CDSCO) has been increased from 111 in 2008 to 510 in 2018.
- VI. The testing  capacities of Central Drugs Testing  Laboratories under CDSCO are bei constantly strengthened to expedite testing of drug samples in the country.
- VII. On 3.4.2017, in order to ensur e efficacy of drugs, the Drugs and Cosmetics Rules, 1945 have  been  amended  providing  that  applicant  shall  submit  the  result  of  bioequival study along with the application for grant of manufacturing licence of oral dosage f drugs  falling  under  the Category  II  and  Category  IV  of  the  Biopharmaceutical Classification System.
- VIII. 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 manufacturing lic ense, the manufacturing establishment is to be inspected jointly by Drugs Inspectors of Central Government and State Government.