GOVERNMENT OF INDIA

MINISTRY OF HEALTH AND FAMILY WELFARE

DEPARTMENT OF HEALTH AND FAMILY WELFARE

LOK SABHA

UNSTARRED QUESTION NO. 4147

TO BE ANSWERED ON 13TH DECEMBER, 2019

FAILURE OF DRUG SAMPLES

4147. SHRI KHAGEN MURMU:

SHRI ANANTKUMAR HEGDE:

SHRI RAMESHBHAI LAVJIBHAI DHADUK:

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

(a) whether the Central Drugs Standard Control Organisation (CDSCO) in August-September 2019, has submitted any report regarding failure of samples of many drugs including the drugs used in treatment of diseases like Heart, Kidney, Blood Pressure, Thyroid, Malaria etc.;

(b) if so, the details thereof companywise, along with the action being taken by the Government against such companies; (c) whether the Government is aware that spurious drugs including expired drugs with repacking, are openly sold in the country which is harmful to precious human life;

(d) if so, the reaction of the Government thereto along with the number of cases registered related to sale of substandard or counterfeit medicine during the last five years, State/UT-wise;

(e) whether any death has been reported due to use of substandard or counterfeit medicine, if so, the details thereof; and (f) the steps taken/proposed to be taken to check such tendencies in co-operation with the Ministry of Chemicals and Fertilizers and State Governments?

ANSWER

THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND

FAMILY WELFARE

(SHRI ASHWINI KUMAR CHOUBEY)

(a) & (b): Details of drugs declared as spurious/substandard/adulterated/misbranded by Central Drug Testing Laboratories are regularly uploaded on CDSCO website (www.cdsco.nic.in) under the heading “Drug Alert”. Details of such cases of ‘Not of Standard Quality’ during the months of August and September 2019 is enclosed as Annexure-A. These cases include drugs for heart & kidney problems, thyroid, malaria, blood pressure, etc.

Licence for manufacturing, sale & distribution of drugs are granted by the State Licensing Authorities appointed by respective State Governments. State Governments are empowered to take action on violations of any of the provisions of Drugs & Cosmetics Act, 1940 and Rules made thereunder. In all the above cases, the State Drugs Controllers of the concerned State where the drugs were manufactured have been informed accordingly.

(c) & (d): Isolated complaints regarding suspected quality of medicines including expired drugs sold in the country are received. Accordingly, the matter is taken up by Central Drugs Standard Control Organisation (CDSCO) in coordination with State Licensing Authority for action as per the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945

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 and action taken thereon during the last five years is enclosed as Annexure-B.

(e): As per information received from State/UT Drugs Controllers, no complaint has been registered regarding death of any person due to use of substandard or spurious medicine during the last five years and the current year.

(f): Drugs are regulated under the provisions of Drugs and Cosmetics Act and Rules made there under. As stated above, licence for manufacturing, sale & distribution of drugs are granted by the State Licensing Authorities appointed by respective State Governments. State Governments are empowered to take action on violations of any of the provisions of Drugs & Cosmetics Act, 1940 and Rules made thereunder

Further, the Government is committed to ensuring that the quality, safety and efficacy of drugs are not compromised. With this in view, the Government has taken a series of measures including strengthening of legal provisions, conducting workshops and training programmes for manufacturers and regulatory officials and measures such as risk based inspections.