Lok Sabha Question No. 430 (UNSTARRED), answered on 2020-02-04
Subject: BIS Standard for Chemicals
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Bhagwanth Khuba, Saikia Dilip, Ramesh Chander Kaushik, Tapir Gao

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

LOK SABHA UNSTARRED QUESTION No. 430 TO BE ANSWERED ON THE 04 th  February, 2020

## BIS Standard for Chemicals

## 430.   SHRI BHAGWANTH KHUBA:

SHRI DILIP SAIKIA:

SHRI RAMESH CHANDER KAUSHIK:

SHRI TAPIR GAO:

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

- (a) the details of steps taken by department of Pharmaceuticals for standardization and quality improvement;
- (b) whether it is a fact that many chemicals produced and imported in the country are not having BIS standards;
- (c) if so, the details thereof;
- (d)  whether the Government has recently made BIS standard mandatory for some chemicals; and
- (e) if so, the details thereof?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI D. V. SADANANDA GOWDA)

- (a): The manufacture, sale and distribution of drugs are primarily regulated in the country  under  the  provisions  of  Drugs  &  Cosmetics  Act  &  Rules  1945  made thereunder  through  a  system  of  licensing  and  inspection  by  State  Licensing Authorities  appointed  by  respective  State  Governments.  Licensee  is  required  to comply  with  all  the  conditions  of  license  as  prescribed  under  Drugs  &  Cosmetics Rules,  1945  and  State  Licensing  Authorities  are  empowered  to  take  action  on violation of any condition of such licenses including prosecution in appropriate Court of  law.  Central  Drugs  Standard  Control  Organization  (CDSCO)  and  Ministry  of Health & Family Welfare has taken various measure at time to time to ensure quality of drugs in the country.

Major such reforms 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 nonbailable.
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,  32  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 492 in 2019.
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 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.
8. 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.

The  Government  has  also  approved  a  proposal  for  strengthening  the  drug regulatory  system  in  the  country,  both  at  the  level  of  Central  and  the  State Governments at a total expenditure of Rs.1750 crores. Out of this, Rs. 900 crore is for  strengthening  the  central  drug  regulatory  structures  and  Rs.850  crore  is  for strengthening  the  drug  regulatory  system  in  the  States.  During  the  years  2016-17 and  17-18,  Rs.  128.39  crore  has  been  released  under  the  Central  component whereas Rs. 87.90 crore has been allocated during 2018-19 under this component. Rs. 82.90 crore was allocated during the year 2019-20. Under the State component, Rs. 81.36 crore has been released during 2016-17 and 17-18 whereas Rs. 206 crore was allocated during 2018-19 under this component.

- (b)  &  (c):  The  chemicals  sector  is  de-licensed.  The  BIS  standards  of  majority  of chemicals  &  petrochemicals  are  voluntary  in  nature.  Bureau  of  Indian  Standards (BIS) has formulated approximately 853 standards on chemical & chemical products. Further there are many chemicals and chemical products produced and imported in the country, which are not having BIS standards.
- (d) & (e): The Government has recently made BIS Standards mandatory for Caustic Soda, Acetic Acid, Aniline, Methanol and Poly Aluminium Chloride to protect human health, environment, national security and to prevent unfair trade practices.

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