Question : Drug Testing Laboratories

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

(a) whether inadequate number of drug testing laboratories is one of the major reasons for circulation of spurious drugs in the country, if so, the details thereof;

(b) the number of drug testing laboratories functioning and proposed to be opened in the country, State/UT-wise;

(c) the existing mechanism to review the functioning of drug testing laboratories;

(d) whether the Government proposes to launch a campaign to create awareness and ensure public participation against spurious drugs, if so, the details thereof; and

(e) the details of steps taken to reward the whistle blowers and ensure their security as well as to safeguard the interests of honest manufacturer and traders of medicines/drugs in the country?

ANSWER
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND
FAMILY WELFARE
(SHRI ASHWINI KUMAR CHOUBEY)
(a): The prevalence of spurious drugs in the country has been estimated to be 0.0245% in a survey conducted to determine the problem of spurious and not of standard quality drugs in the country (2014-16). The prevalence of such drugs, as such, is very low.

(b): List of State drugs testing laboratories is at Annexure. Currently, there are seven Central Drug Testing Laboratories at Kolkata, Chennai, Mumbai, Chandigarh, Hyderabad, Guwahati and Kasauli.

The Government has approved setting up of six Central laboratories for drugs / cosmetics / Medical devices and ten drug testing laboratories by States and Union Territories.

(c): All aspects relating to functioning of Central Drugs testing laboratories are reviewed and monitored regularly by Drugs Controller General (India) and the Ministry of Health & Family Welfare. Similarly, the States/UTs also review the functioning of their laboratories periodically.


(d): 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 legal provisions, workshops and training programmes for manufacturers and regulatory officials and measures such as risk based inspections. However, no specific campaign is proposed in this regard.

(e): A Whistler Blower Scheme to encourage vigilant public participation for detection of movement of spurious drugs in the country is already in place. The scheme provides for suitably rewarding informers for providing concrete information to regulatory authorities in respect of movement of NSQ/misbranded/adulterated/spurious drugs.

As per Whistle Blower Policy, the identity of the whistle blower/informer is to be kept secret and will be known only to the concerned designated official. It will be the responsibility of the concerned officials to keep the details of the whistle blower/informer secret.