News Cubic Studio

Truth and Reality

Export of Drug Formulations and Biologics registers continuous growth over past three years

The measures taken by Department of Commerce to promote exports include various schemes under the Foreign Trade Policy (FTP), assistance under the Market Access Initiative (MAI) scheme, setting up district export hubs, Transport and Market Assistance Scheme etc. Trade delegations/buyer-seller meets with various countries are regularly organized for the benefit of exporters. Airfare support is also provided to the exporters with a turnover of Rs.30crore and below to encourage participation in business delegations/trade fairs.

The quantum of pharmaceutical exports of past three years, category-wise is as under:

(In Million USD)

S.No. Category 2018-19 2019-20 2020-21
1 Bulk Drugs, Drug Intermediates 3911 3886 4430
2 Drug Formulations, Biologics 14389 15941 19042

Department of Commerce, in partnership with other stakeholders, is working towards boosting our presence in under penetrated/potential international markets viz. North East Asia, Africa, Middle East, Latin America, South East Asia etc. The Department is also actively taking up with MoHFW/CDSCO for promotion of newer products such as gene therapy, bio-similars, and specialty drugs to drive the next phase of export growth.

This information was given by the Minister of Health & Family Welfare and Chemicals & Fertilizers, Shri Mansukh Mandaviya in a written reply in Lok Sabha today.

Percentage of spurious drug samples shows consistent decline over the years

As per Central Drugs Standard Control Organisation (CDSCO), isolated complaints regarding spurious drugs are received in CDSCO. As and when such complaints are received, based on merit, the matter is taken up by the CDSCO in coordination with State/UT Drugs Controller for action as per the provisions of the Drugs & Cosmetics Act, 1940 and the Drugs & Cosmetics Rules, 1945. The information received from Drugs Controllers of various States/UTs during last three years and current year in this context is as under:

 

Financial Year No. of drug samples tested No. of drug samples declared spurious/ adulterated Percentage of drug samples declared spurious/  adulterated
2017-18 82599 236 0.28
2018-19 79604 205 0.27
2019-20 81329 199 0.24
2020-21* 69272 139 0.20

 

Corresponding information received from various Zonal/Sub-zonal offices of CDSCO is as under:

 

Financial Year No. of drug samples tested No. of drug samples declared spurious/ adulterated Percentage of drug samples declared spurious/  adulterated
2017-18 7088 2 0.028
2018-19 10382 5 0.048
2019-20 9299 12 0.12
2020-21* 4237 1 0.02

*The information of FY 2020-21 is upto 31st January, 2021 only.

Further, amidst reports received of fake & spurious Covid-19 management drugs, CDSCO has requested all States/UTs Drugs Controllers through several advisories to instruct their enforcement staff to keep strict vigil especially at sensitive places and to take stringent action against the offenders by conducting special drive of monitoring and investigation.

As per information available from various State Licensing Authorities, in cases of fake &spurious Covid management drugs, various enforcement actions like Drug seizure, Arrests of accused persons / registration of FIR etc. have been carried out by the States/UTs Drugs Controllers. CDSCO and Ministry of Health and Family Welfare have taken various regulatory measures to ensure the quality of medicines distributed in the country which are as under:

  1. The Drugs and Cosmetics Act, 1940 was amended under the 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, 33 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 the Central Drugs Standard Control Organization (CDSCO) has been increased from 111 in 2008 to 492 (in Jan, 2021).
  5. The testing capacities of Central Drugs Testing Laboratories under the 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 license 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.

 

Joint inspection of the licensed manufacturing premises 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 is also provided for.

 

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.

 

This information was given by the Minister of Health & Family Welfare and Chemicals & Fertilizers, Shri Mansukh Mandaviya in a written reply in Lok Sabha today.