Question : Manufacturing of Faulty and Adulterated Drugs

(a) whether the Government is taking any steps to combat the manufacturing of faulty and adulterated drugs, if so, the details thereof and if not the reasons therefor;
(b) the steps taken by the Government to improve manpower in the area of drug regulation, i.e. drug regulators and the details thereof;
(c) whether the Government has taken measures to combat the huge time gap between the sale of faulty drugs in the market and the notification given for recall of the batch, if so, the details thereof and if not, the reasons therefor; and
(d) whether the Government has any data on the number of faulty drugs manufactured in the last five years, if so, the action taken against the manufacturers in such cases?

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

(a) to (c): The manufacture, sale and distribution of drugs in the country is regulated under the provisions of Drugs & Cosmetics Act, 1940 and its Rules through a system of licensing and inspection. Licenses for manufacture, sale and distribution of drugs are granted by the State Licensing Authorities (SLAs) appointed by respective State Governments. SLAs are legally empowered to take stringent action against violation of provisions of the Act and Rules.
The licensees are required to comply with all the conditions of license and follow Good Manufacturing Practices (GMP) of Drugs Rules to ensure that the drugs manufactured by them are safe and of standard quality.
The Government has taken a series of measures including strengthening of legal provisions, workshops and training programmes for manufacturers and regulatory officials and measures such as risk based inspections.
Further, under the Centrally Sponsored Scheme for ‘Strengthening of the States’ Drug Regulatory System’, funds have been released for upgrading of existing State Drugs laboratories, setting up of new drug testing laboratories and upgrading of existing State Drugs Control Offices.
(d): As per information received from various State/UT Drugs Controllers, number of drugs samples tested, number of drugs samples declared sub-standard and spurious/ adulterated during the last five years are as below:
Year No. of drugs samples tested No. of drugs samples declared not of standard quality % No. of drugs samples declared not of standard quality No. of drugs samples declared spurious/ adulterated % No. of drugs samples declared spurious/ adulterated No. of prosecutions No. of persons arrested
2016-17 76,721 2,780 3.6 123 0.16 186 106
2017-18 82,599 2783 3.36 236 0.28 131 163
2018-19 79,604 2,549 3.35 205 0.27 484 153
2019-20 81329 2497 3.07 199 0.24 421 220
2020-21 84874 2652 3.12 263 0.31 236 164

In respect of Zonal/Sub-Zonal offices of CDSCO, the information is as below:
Year No. of drugs samples tested No. of drugs samples declared not of standard quality % No. of drugs samples declared not of standard quality No. of drugs samples declared spurious/ adulterated % No. of drugs samples declared spurious/ adulterated No. of prosecutions No. of persons arrested
2016-17 5207 146 2.80 NIL 0.0 21 NIL
2017-18 7088 381 5.37 2 0.028 17 6
2018-19 10382 310 2.98 5 0.048 31 4
2019-20 9299 307 3.30 12 0.12 28 6
2020-21 5460 170 3.11 3 0.055 12 NIL

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