Lok Sabha Question No. 54 (STARRED), answered on 2016-11-18
Subject: Use of Banned/Spurious Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: HARI MANJHI, KANWAR SINGH TANWAR

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

## LOK SABHA STARRED QUESTION NO. 54 TO BE ANSWERED ON THE 18 TH NOVEMBER , 2016 USE OF BANNED/SPURIO US DRUGS

## †*54. SHRI HARI MANJHI: SHRI KANWAR SINGH TANWAR:

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

- (a) whether there are reports that a number of patients have lost their li administration  of  wrong,  spurious  and  expired  drugs  by  the  doct ors  in  various Government and Corporate Hospitals and if so, the details thereof and action thereon;
- (b) whether the Government has taken note of the fact that medicines are bei online and offline without proper prescription by the doctors i nducing the chances of drug abuse and if so, the details thereof and preventive steps taken in this
- (c) whether the sale of spurious and expired drugs is going on unabated i towns and villages especially in remote and far - flung areas of th e country and if so, the details thereof;
- (d)  whether  bar  coding  for  medicines,  training  for  drug  manufacturers  and tolerance  towards  sub - standard  medicines  is  a  matter  of  grave  concern  for  t Government and if so, the steps taken by the Government to protect the consumer from counterf eit/sub - standard drugs being sold online and to regulate the e- pharmacy web business; and
- (e) the details of drug testing laboratories and new laboratories proposed to up, State/UT - wise .

## ANSWER THE MINISTER OF HEALTH AND FAMILY WELFARE ( SHRI JAGAT PRAKASH NADDA )

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA

## TH

## STARRED QUESTION NO. 54* FOR 18 NOVEMBER , 2016

(a): Stray  incidents  of  this  nature  get  reported  in  the  media  from  time  t These  are  investigated  by  the  Central  and  the  State  Governments  and  neces remedial action is taken.

(b): Sale and distribution of drugs in the country is regulated under the pr of the Drugs & Cosmetics Act, 1940 and Rules thereunder . In accordance with these Rules, drugs specified in Schedules H, H1 and X cannot be sold except on, a accordance  with  the  prescription  of  a  Registered  Medical  Practitioner  f licensed premise. Some instances of online sale of medicines had been r eported in the media. Wherever any violation is noticed, suitable action is taken by t Licensing Authorities.

(c): No such reports of unabated sale of spurious and expired drugs in small and  villages  of  the  country  has  come  to  the  notice  of the  Central  Government. However, a few stray incidents are reported from time to time and action provisions of the law is taken in such cases.

(d): The Government is committed to ensuring that the quality, safety and eff of drugs are not compro mised. With this in view, the Government has taken a seri of measures. These include:

(i) stringent penalties including making certain offences cognizable an -bailable;

(ii) establishment of special designated Courts for trial of offences und s and Cosmetics Act for speedy disposal of cases;

(iii) announcement of a Whistle Blower Scheme to encourage vigilant pub participation for detection of movement of spurious drugs in the country;

(iv) issuance of guidelines to the State Drugs Controllers for taking acti samples of drugs declared spurious, adulterated, misbranded or 'not of standard quality';

(v) instructions to the concerned staff to keep a vigil and draw samples for test and anal ysis for monitoring the quality of drugs moving in the count

(vi)  increase  in  the  number  of  posts  in  the  Central  Drugs  Standard  Co Organization (CDSCO);

(vii) re - equipping of drug testing laboratories with state - of - the - art equipment;

(viii) larg e scale nation -wide survey to determine the 'not of standard quality' drugs;

(ix) conducting workshops and training programmes for skill enhancement areas  such  as  Good  Manufacturing  Practices  (GMP),  Good  Laboratory Practices  (GLP),  Good  Distribution  Pr actices  (GDP),  Good  Clinical  Practice (GCP) and  Good Storage and Distribution Practices (GSP) to regulators industry in partnership with other Departments, industry and regulators o countries including USA and European Union.

(x)  Conducting  tra ining  programmes  for  laboratory  personnel  of  State  and Central laboratories to upgrade their analytical capabilities and skill s

(xi) risk based inspections of manufacturing facilities have been started

Bar coding has already been started for expo rts. As far as bar coding for domestic supplies is concerned, a draft notification had been issued on 03.06.2015 t objections and suggestions from the stakeholders.  The notification was, ho not finalized keeping in view the reservations of m anufacturers regarding high cost of bar coding.

The  issue  relating  to  online  sale  of  drugs  has  been  examined  by  the Consultative Committee (DCC) and a Sub - Committee of the DCC. The DCC has finalised its recommendations for establishment of a robust system to regulate online sale of drugs before permitting such sale.

(e): List  of  State  drugs  testing  laboratories  is  at Annexure .  Currently,  there  are seven Central Drug Testing Laboratories at Kolkata, Chennai, Mumbai, Chandiga Hyderabad, Guwahati and Kasauli. The Government has approved setting up of six more Central laboratories for drugs / cosmetics / Medical devices.

******

## Annexure  to  the  Statement  referred  to  in  reply  to  the  Lok  Sabha  Starred Question No. 54 for 18th November, 2016

| S.NO   | State            | Name and Address of Laboratory                                                                                                                |
|--------|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 1      | Goa              | Food & Drugs Laboratory, Bambolim Goa                                                                                                         |
| 2      | Karnataka        | Office of Chief Scientific Officer, Drugs Testing Laboratory, Palace Road, Bangalore-560001                                                   |
|        |                  | Office of Chief Scientific Officer, Regional Drugs Testing Laboratory, Ground Floor, 2nd Cross, 2nd Stage, Raghavendra Colony, Bellary-585101 |
|        |                  | Office of Chief Scientific Officer, Regional Drugs Testing Laboratory, Plot No. 193, Industrial Area, 2nd Stage, Raipur, Dharwad-580604       |
| 3      | Kerala           | Drugs Testing Laboratory, Red Cross Road, Thiruvananthapuram, Pin-695035                                                                      |
|        |                  | Regional Drugs Testing Laboratory, Ernakulam                                                                                                  |
| 4      | Himachal Pradesh | Composite Testing Lab,Kandaghat,Solan,HP                                                                                                      |
| 5      | Andhra Pradesh   | Drugs Control Laboratory, Siddhartha Medical College Campus, Vijaywada-520008                                                                 |
| 6      | Gujarat          | Food and Drug Laboratory, Near Polytechnic, Vadodara                                                                                          |
| 7      | Tamil Nadu       | Government Analyst, Drugs Testing Laboratory, Teynampet(DMS Campus) Chennai- 6.                                                               |
|        |                  | Government Analyst, Dept. of Biological Control, King Institute of Preventive Medicine Research, Guindy, Chennai- 32                          |
| 8      | Rajasthan        | Drugs testing laboratory, Mandir marg, sethi colony, Jaipur (Rajasthan)-302004                                                                |
| 9      | Puducherry       | Department of Food & Drug Testing, Drug Testing Laboratory, Gorimedu                                                                          |
| 10     | Chattishgarh     | Drugs testing Laboratory, Kalibadi Raipur, Chhattisgarh- 492001                                                                               |
| 11     | Punjab           | Drug testing laboratory, Chandigarh                                                                                                           |
| 12     | Bihar            | Bihar Drugs control laboratory , Agamkuan, Patna                                                                                              |
| 13     | Odisha           | State drug testing and research laboratory, Odisha, Bhubaneswar                                                                               |
| 14     | Jharkhand        | Jharkhand state drugs testing laboratory, Namkun, Ranchi- 834010.                                                                             |

|   15 | Tripura         | State Drug Testing Laboratory, Agartala                                                                                             |
|------|-----------------|-------------------------------------------------------------------------------------------------------------------------------------|
|   16 | Meghalaya       | Food & Drug Laboratory, Pesteur Institute, Shillong, Meghalaya - 793001                                                             |
|   17 | Jammu & Kashmir | Combined Food & Drug Laboratories, Patoli Mangotrian, Jammu                                                                         |
|   18 | Maharashtra     | Drug Control Laboratory, Survey No. 341, Bandra kurla Complex, bandra (East), 400051                                                |
|   18 | Maharashtra     | Drug Control Laboratory, Third Floor, Nath Super Market, Aurangpura, Aurangabad-431001                                              |
|   19 | Haryana         | Drug testing laboratory, Sector 11D, Chandigarh                                                                                     |
|   20 | West Bengal     | EFRAC, Subhash Nagar, P. O. Nilganj Bazar, Barasat, Kolkata-700121                                                                  |
|   21 | Telangana       | Drugs Control Laboratory, Vengal Rao Nagar, Hyderabad                                                                               |
|   22 | Chandigarh      | Drug testing laboratory, Chandigarh (The Gov. of UT Chandigarh approved Drugs Testing Laboratory of Punjab State for UT Chandigarh) |
|   23 | Uttar Pradesh   | Government analyst, UP O/o Food and drug testing laboratory, Sector C, Aliganj, Lucknow                                             |
|   24 | Delhi           | Drug Testing Laboratory, A-20, Lawrence Road, Delhi- 110035                                                                         |
|   25 | Madhya Pradesh  | DRUG TESTING LABORATORY, Food & Drugs Administration, Idgah Hills, Bhopal (M.P.) - 462032                                           |
|   26 | Uttarakhand     | Drug Testing Laboratory, Dehradun                                                                                                   |