Lok Sabha Question No. 2078 (UNSTARRED), answered on 2021-12-10
Subject: Quality Medicines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Jaswantsinh Sumanbhai Bhabhor, Naranbhai Bhikhabhai Kachhadiya, Parbatbhai Savabhai Patel

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

LOK SABHA UNSTARRED QUESTION NO. †2078 TO BE ANSWERED ON 10 th  DECEMBER, 2021

## Quality Medicines

## †2078.   SHRI JASWANT SINGH BHABHOR: SHRI NARANBHAI KACHHADIYA: SHRI PARBATBHAI SAVABHAI PATEL:

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

- (a) the measures being taken by the Government to produce quality medicines for all the people across the country;
- (b) whether pharmaceutical industry in the country is working to address the challenges posed by climate change, biodiversity and environmental impact;
- (c) if so, the details thereof; and
- (d)  the  measures  being  taken  by  the  Government  to  ensure  new  and  innovative  means  of drugs/treatment available in rural and tribal areas of Gujarat particularly in Dahod?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS & FERTILIZERS (DR. MANSUKH MANDAVIYA)

(a): As  per  information  provided  by  the  Central  Drugs  Standard  Control  Organization (CDSCO) under the Ministry of Health & Family Welfare, the Organization regulates safety, efficacy and quality of the drugs, medical devices and Cosmetics as per the provisions of Drugs and Cosmetics Act 1940 & Rules made thereunder. CDSCO and Ministry of Health & Family Welfare from time to time have taken various measures for ensuring the quality of drugs in the country, such as:

- i. Drugs and Cosmetics Act, 1940 was amended in the year 2008 to provide stringent penalties for manufacturer of spurious and adulterated drugs and certain offences have also been made cognizable and non-bailable.
- ii. States/UTs were requested to set up Special Courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal. So far, 33 states have already set up designated Special Courts.
- iii. Guidelines for taking action on samples of drugs declared as 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.
- iv. Number of sanctioned posts in CDSCO have been increased from 111 in 2008 to 492 in January, 2021.
- v. Testing capacities of Central Drugs Testing Laboratories under CDSCO are being constantly strengthened to expedite testing of drug samples in the country.
- vi. In order to ensure efficacy of drugs, the Drugs and Cosmetics Rules 1945 have been amended  in  April,  2017  providing  that  applicant  shall  submit  the  result  of bioequivalence study along with the application for grant of manufacturing License of oral dosage form of drugs falling under the Category II and Category IV of the Biopharmaceutical Classification System.
- vii. Drugs and Cosmetics Rules 1945 have been amended in October, 2017 making it mandatory  that  before  the  grant  of  manufacturing  license,  the  manufacturing establishment  is  to  be  the  inspected  jointly  by  Drugs  Inspectors  of  the  Central Government and the State Government concerned. Further, the licensed manufacturing  premises  are  to  be  inspected  jointly  by  the  Drugs  Inspectors  of Central  Government  and  State  Government  concerned  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.
- viii. Drugs and Cosmetics Rules 1945 have been amended  in April, 2018 making it mandatory that the applicants for all drugs shall submit evidence of stability, safety of  excipients  etc.  to  the  State  Licensing  Authority  before  grant  of  product manufacturing license by the Authority.
- ix. Government has 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. 1,750 crores.

(b) & (c): Ministry  of  Environment  Forest  and  Climate  Change,  in  consultation  with the Central Pollution Control Board (CPCB), has notified discharge norms for pharmaceutical industries in January, 2020 under the Environment (Protection) Act, 1986. These norms are reviewed  and  revised  periodically.  The  notified  norms  are  enforced  by  the  State  Pollution Control Boards (SPCB) / Pollution Control Committees in the consent order (CTO-Consent to operate) issued under the Air Act (PCP), 1981 and the Water Act, 1974. Further the units are encouraged  to  reduce  their  waste  water  generation  by  technological  advancement  and reuse/recycle of wastewater.

All highly polluting 17 categories of industries, including bulk drugs and formulations (pharmaceutical) industry, have been directed to install online continuous effluent/emission monitoring systems (OCEMS). CPCB from time to time carries out surprise inspection of the industries  for  checking  performance  and  operational  status  of  pollution  control  measures adopted by the industries. During the inspection/manual monitoring, if any industry is found non-complying the norms, then closure direction is issued under section 5 of the Environment (Protection) Act, 1986 to the unit for rectification or up-gradation of Effluent Treatment Plant (ETP)/ Air Pollution Control devices (APCDs).

(d): Public Health being a State subject, the primary responsibility of supply of medicines and  management  of  hospitals  lies  with  the  States/UTs  concerned.  However,  the  National Council  for  Clinical  Establishments  under  the  Ministry  of  Health  &  Family  Welfare (MoH&FW) has approved a standard list of medical procedures and a standard template for costing of medical procedures and the same have been shared with all the States, including Gujarat, for appropriate action.

Further, in order to promote innovations and Research & Development so as to ensure that the new and innovative drugs are made available to all the citizens, exemption from price control under the Drugs (Prices Control) Order, 2013 (DPCO, 2013) is provided for a period of five years to the manufacturers producing a new drug patented under the Indian Patent Act, 1970 (39 of 1970).

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