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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 the 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 the last three years and the 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 up to 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:
- The Drugs and Cosmetics Act, 1940 was amended under the Drugs & Cosmetics (Amendment) Act 2008 to provide stringent penalties for the manufacture of spurious and adulterated drugs. Certain offenses have also been made cognizable and non-bailable.
- The States / UTs were requested to set up special courts for the trial of offenses under the Drugs and Cosmetics Act for speedy disposal. So far, 33 States have already set up designated special Courts.
- 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.
- 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).
- The testing capacities of Central Drugs Testing Laboratories under the CDSCO are being constantly strengthened to expedite the testing of drug samples in the country.
- On 3.4.2017, in order to ensure the 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 the oral dosage form of drugs falling under the Category II and Category IV of the Biopharmaceutical Classification System.
- 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 the 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, the safety of excipients, etc. to the State Licensing Authority before grant of product manufacturing license by the Authority.
