Lok Sabha Question No. 4522 (UNSTARRED), answered on 2019-01-08
Subject: Generic Medicines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: RAMESH POKHRIYAL NISHANK

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

## LOK SABHA

UNSTARRED QUESTION No. 4522 TO BE ANSWERED ON THE 8 th  January, 2019

## Generic Medicines

†4522. DR. RAMESH POKHRIYAL 'NISHANK':

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a)  the  details  of  steps  taken/being  taken  by  the  Government  to  address  the  lack  of quality in the Generic Medicines being used in the country at present;
- (b)  the  steps  taken/being taken by the Government to strengthen the supply chain of Generic Medicines in the backward, rural, hilly and inaccessible areas;
- (c) whether the country has adequate availability of laboratories and human resources to test the medicines; and
- (d)  the  manner in which the quality of medicine is proposed to be ensured in view of lack of testing laboratories in remote areas of the country?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF ROAD TRANSPORT AND HIGHWAYS; MINISTRY  OF  SHIPPING  AND  MINISTRY  OF  CHEMICALS  AND  FERTILIZERS (SHRI MANSUKH L. MANDAVIYA)

- (a): Manufacturing, sale and distribution of Drugs in the country are regulated under the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945 made thereunder through a system of licensing and inspection. License for manufacturing, sale and distribution of Drugs  are  granted  by  State  Licensing  Authorities  appointed  by  respective  State Governments. Manufacturers are required to comply with the conditions of license and follow Good Manufacturing Practices (GMP) to ensure that the drugs manufactured by them  are  of  standard  quality.  All  drugs  manufactured  in  the  country  are  required  to comply with the same standards prescribed under the said Act and Rules.  The State Licensing Authorities are empowered to take action in case of any violation of above requirements. Further, CDSCO & Ministry of Health has taken various steps to ensure the quality of drugs including generic drugs manufactured/ marketed in the country. Details are as under:
1. 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.
2. 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.
3. 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.
4. The number of sanctioned posts in Central Drugs Standard Control Organization (CDSCO) has been increased from 111 in 2008 to 510 in 2018.
5. The testing capacities of Central Drugs Testing Laboratories under CDSCO are being constantly strengthened to expedite testing of drug samples in the country.
6. On  3.4.2017,  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.
7. 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.
8. Draft Rules have been published vide GSR 999 (E), dated 5th 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
9. 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.

(b): Under 'Pradhan Mantri Bhartiya Janaushadhi Pariyojana' (PMBJP), quality generic medicines  are  made  available  at  affordable  prices  to  all.  As  on  03.01.2019,  4735 PMBJP Kendras are functional in 35 States/Union Territories and 646 districts of the country  in  order  to  make  available  more  than  800  medicines  and  154  surgicals  and consumables. In order to strengthen supply  chain  of  the  scheme across  the  country, following steps have been taken by the Government:

- (i) 1  Central  Ware  House  (CWH)  is  established  at  Bilaspur,  Gurugram, Haryana for stocking and supplying the medicines, surgicals and consumables with an IT enabled supply chain management system.
- (ii) 52  Distributors  have  also  appointed  in  different  parts  of  the  country  for ensuring continuous supply of medicines, surgicals and consumables to PMBJP Kendras functioning across the country.
- (iii) Recently,  an  IT  enabled  end-to-end  supply  chain  system  has  also  been introduced  for  making  available  full  range  of  medicines  directly  from  Central Ware  House  (CWH)  to  PMBJP  Kendras  to  save  time  and  cost,  through  auto ordering  and  dispatching.  To  implement  this  system,  a  professional  agency namely  M/s  Ethics  Infinity  Pvt.  Ltd.  has  been  appointed  by  BPPI  for  providing end-to-end supply chain management solution for the scheme under which the products are supplied directly from CWH to PMBJP Kendras to save time and cost.
- (iv) Installation  of  'Point  of  Sale'  (POS)  software  application  at  all  PMBJP Kendras is under process. As on date, more than 3000 PMBJP Kendras have been  connected  with  POS  software  out  of  4735  PMBJP  Kendras  functioning across the country.
- (v) Recently,  BPPI  has  also  set  up  2  Regional  Ware  Houses  (RWHs),  one each  at  Guwahati  and  Bengaluru  for  ensuring  uninterrupted  supply  of  the products.
- (c)  &  (d):  There  are  total  31  Govt.  Drug  testing  Laboratories  set  up  by  State Governments and total 07 Drug testing Laboratories set up by Central Government.
- The testing capacities of Central Drugs Testing Laboratories under CDSCO are being constantly strengthened to expedite testing of drug samples in the country.
- The number of sanctioned posts in Central Drugs Standard Control Organization (CDSCO) has been increased from 111 in 2008 to 510 in 2018.
- 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.
- One  of  the  major  components  of  the  State  scheme  is  to  upgrade  State  Drug Testing  Laboratories.  Accordingly,  the  activities  planned  in  the  States  and  the  Union Territories  include  setting  up  of  10  drug  testing  laboratories  and  up-gradation  of  31 existing drug testing laboratories.

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