Lok Sabha Question No. 3300 (UNSTARRED), answered on 2021-12-17
Subject: Acute Lymphoblastic Leukaemia
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Jayant Sinha

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

## LOK SABHA UNSTARRED QUESTION NO. 3300 TO BE ANSWERED ON 17 TH  DECEMBER, 2021

## ACUTE LYMPHOBLASTIC LEUKAEMIA

## 3300.    SHRI JAYANT SINHA:

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

- (a)  whether  the  Government  proposes  to  take  action  to  enhance  the  quality  of  the  native Biogenerics used for treatment of Acute Lymphoblastic Leukaemia (ALL);
- (b) if so, the details thereof; and
- (c) the initiative taken by the Government to do a quality-check, and enhance the quality of cancer drugs available in the country?

## ANSWER

## THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (DR. BHARATI PRAVIN PAWAR)

(a) and (b):Manufacturing, sales and distribution of drugs in the country are regulated under the provision of Drugs & Cosmetic Act, 1940 and Drugs Rules,1945. It is made there under through a system of Licencing and Inspection. License for sale and distribution of drugs are granted  by  State  Licensing  Authorities  appointed  by  respective  State  Governments.  The Licensees are required to comply with all the conditions of license including the conditions that the licensee is required to comply with the requirement of Good Manufacturing Practices as prescribed in Schedule M of the Rules and before release of the product in the market each batch is required to be tested to ensure the quality of the drug.

The State  Licensing Authorities are  empowered  to take action against any  violation of the conditions of licenses.

Various  drugs  are  approved  for  treatment  of  Acute  Lymphoblastic  Leukaemia  (ALL). However, there is no such terminology like Biogenerics in the said Act and Rules thereunder.

- (c):  The Central Drugs Standard Control Organisation(CDSCO) and Ministry of Health and Family Welfare have taken various regulatory measures to ensure the quality of medicines in the country.

The details are provided below,

- 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  testing  capacities  of  Central  Drugs  Testing  Laboratories  under  CDSCO  are  being constantly strengthened to expedite testing of drug samples in the country.
- 5) 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.
- 6)  On  27.10.2017,  the  Drugs  and  Cosmetics  Rules,  1945  have  been  amended,  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 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.
- 7)  On  10.04.2018,  the  Drugs  and  Cosmetics  Rules,  1945  have  been  amended,  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) The Government had 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 crores were for strengthening the central drug regulatory structures and Rs.850 crores were for strengthening the drug regulatory system in the States. During the years 2016-17 and 2017-18, Rs. 128.39 crore had been released under the Central component  whereas  Rs. 87.90 crore had been allocated during 2018-19  under this component. Under the State component, Rs. 81.36 crore had been released during 2016-17 and  2017-18  whereas  Rs.  206  crores  had  been  allocated  during  2018-19  under  this component.