Lok Sabha Question No. 1087 (UNSTARRED), answered on 2016-07-22
Subject: Medical Devices and Medicines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: SUDHEER GUPTA, KUNWAR HARIBANSH SINGH, SUNIL BALIRAM GAIKWAD, T. RADHAKRISHNAN, GAJANAN CHANDRAKANT KIRTIKAR, VIJAY KUMAR S.R., BIDYUT BARAN MAHATO, ASHOK SHANKARRAO CHAVAN

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

## LOK SABHA UNSTARRED QUESTION NO. 1087 TO BE ANSWERED ON 2 2 ND JULY, 2016

## MEDICAL DEVICES AND MEDICINES

## 1087. SHRI SUDHEER GUPTA:

KUNWAR HARIBANSH SINGH:

DR. SUNIL BALIRAM GAIKWAD:

SHRI T. RADHAKRISHNAN:

SHRI GAJANAN KIRTIKAR:

SHRI S.R. VIJAYAKUMAR:

SHRI BIDYUT BARAN MAHATO:

SHRI ASHOK SHANKARRAO CHAVAN:

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

- (a) whether the high cost of importedmedical devices due to higher import duty thereon making healthcare expensive and if so, the details thereof;
- (b) whether the Government proposes to promote indigenous manufacturing of medical devices to reduce its high costs and if so, the detai ls thereof and the action taken thereon;
- (c)  whether  the  Government  has constituted/proposes  to  constitute  a  task force/committee  to regulate price of patented medical devices and medicines and if so, the outcome thereof;
- (d)  whether  the  Government  has  p ut  inplace  a  mechanism  to  improve  the  quality of drugs/medicines and if so, the details thereof; and
- (e) the extent to which said mechanism has enabled to maintain optimum drug quality?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI FAGGAN SINGH KULASTE )

- (a): Levy of customs duty impacts the price of imported medical devices. It would , however not be correct to state that the prices of medical devices are higher solely due to such levied. In case of life saving drugs and medical devices, the Department of Revenue ex certain  drugs  and  medical  devices  from  customs  duty  based  on  th e  recommendation  of  the Department of Health and Family Welfare.

(b): Manufacture of medical devices in the country is an important component of the Actio in respect of pharmaceutical sector which is one of the identified sectors under 'Make in India'. In pursuance of this, a series of decisions including identifying suitable locations f Device Parks and formulation of the National Medical Device Policy have been taken.

(c): Based on the report of the Core Committee on National List of Esse ntial Medicines (NLEM), the  Government  has  brought  out  NLEM,  2015.  National  Pharmaceutical  Pricing  Authority (NPPA) has also revised the Schedule under the Drugs Price Control Order (DPCO), 2013 bring it in conformity with the new NLEM. Presently, there is no proposal with the Government to include all medical devices in the NLEM. However, the Committee set up to examine essentiality of coronary stents has rendered its report. The recommendation of the Commit inclusion of cardiac Stents in NLE M, 2015 has been accepted by the Government.

(d) & (e): The manufacturing, sale and distribution of drugs in the country is regulated provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945 thereunder through a system licensing and inspecti on. Licenses for manufacture, sale and distribution of drugs are grante the State Licensing Authorities (SLAs) appointed by respective State Governments. SLAs legally empowered to take action against violations of any provision of the Act.

Further, the Government is committed to ensuring that the quality, safety and effic drugs are not compromised. With this in view, and to check the marketing and manufacturin spurious, adulterated, misbranded, sub - standard and expired drugs in the country, the Government has taken a series of measures. These include stringent penalties including m certain offences cognizable and non - bailable; establishment of special designated Courts for tri of offences under the Drugs and Cosmetics Act for speedy disposal of cases; announcement of a Whistle Blower Scheme to encourage vigilant public participation for detection of movemen spurious drugs in the country; issuance of guidelines to the State Drugs Controllers fo action  on  samples  of drugs  declared  spurious,  adulterated,  misbranded  or  'not  of  standard quality'; maintaining a vigil and draw samples of drugs for test and analysis for monitoring the quality  of  drugs  moving  in  the  country;  increase  in  the  number  of  posts  in  Central Standard  Control  Organisation  (CDSCO);  re - equipping  the  drug  testing  laboratories  with  the state  of  the  art  equipment;  large  scale  nation -wide  survey  to  determine  the  'not  of  standard quality' drugs; conducting workshops and training programmes for skill en hancement in areas such  as  Good  Manufacturing  Practices  (GMP),  Good  Laboratory  Practices  (GLP),  Good Distribution Practices (GDP), Good Clinical Practices (GCP) and Good Storage and Distribu Practices (GSP) to regulators and industry in partnership wit h other Departments, industry and regulators of other countries including USA and European Union. Several training program have also been conducted for laboratory personnel of State and Central Laboratories to u their  analytical  capabilities  and  s kill  sets.  The  measures  taken  have  helped  in  ensuring  the quality, safety and efficacy of drugs manufactured in the country as also drugsimported into the Country.