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Mashlekar Committee favours death sentence for spurious drug
New Delhi, Aug 12: In `more deterrent` measures against spurious drugs, the Mashelkar Committee has recommended death penalty for those who cause `grievous body harm or loss of life`.
New Delhi, Aug 12: In "more deterrent" measures against spurious drugs, the Mashelkar Committee has recommended death penalty for those who cause "grievous body harm or loss of life".
Hitting out at the inadequate and weak drug control infrastructure at the state and central level, the committee also proposes a structure called Central Drug Administration (CDA) which could be established by elevating the Central Drug Standards Control Organisation (CDSCO).
The Drug and Cosmetics Act should be suitably amended and the maximum penalty for sale and manufacture of spurious drugs causing grievous hurt or death enhanced from life imprisonment to death, the committee said in a report, presented to Health Minister Sushma Swaraj today. The government should also make the penalties more deterrent for other related offences, the report said.
Calling for effective deterrence against offenders at the investigation level itself, the report said a specific provision in the Drugs and Cosmetics Act would allow persons indulging in spurious drug offences to be detained for a minimum period.
There is a need to make a distinct provision in the DCA itself declaring all offences related to spurious drugs as cognizable and non-bailable, the report said. It is necessary to involve police authorities in addition to drugs inspectors and authorise them to file prosecutions for spurious drugs under the Drugs and Cosmetics Act, it said.
Noting that most of the cases relating to spurious drugs remained undecided for years, the committee suggested a separate provision for speedy trials of such offences.
Regretting that the level of enforcement of the Drugs and Cosmetics Act, in existence for the past 56 years, was "far from satisfactory", the committee said though the idea for setting up of a National Drug Authority (NDA) had been reiterated many times, it was not implemented.
The existing infrastructure at the central and states was not adequate to perform the assigned functions efficiently and speedily, it said.
However, creating another authority would not solve the problem, it said adding it was essential to strengthen the existing organisations to enable them to undertake all the functions envisaged for NDA. "A strong well-equipped and professionally managed CDSCO, which could be given the status of Central Drug Administration (CDA) was the most appropriate solution," the committee said.
As the onus of monitoring drug manufacturing standards, drawing and testing of samples and taking legal action against infringes rested with state drug regulatory agencies, it was essential that the state governments strengthen and support their drug control organisations, the committee said.
The problems of fake drugs were also due to inadequate testing facilities, shortage of drug inspectors, non-uniformity of enforcement, lack of specially-trained cadres for specific regulatory areas, non-existence of data bank and non-availability of accurate information, it said.
Despite several directions from the central government, many state governments are yet to upgrade the drug testing facilities, it said.
According to the information received from 26 states/union territories, only 15 drug testing laboratories are functioning. Out of these only seven were reasonably equipped and the rest didn't even have bare minimum equipment.
The committee also recommended a scientifically and statistically valid study to evaluate and quantify the extent of the problem of spurious drugs at various levels in the supply chain at the regional and national levels. The government should provide the funds for the study which should take place at the earliest.
Stating that responsibility for effective management of the issue of spurious drugs also came to medical and para-medical professionals, pharmaceutical companies, patients, media, distributors, it said the industry and trade associations should play a more active and collaborative role to arrest the menace.
The government had decided the committee under the chairmanship of Dr R A Mashelkar to examine all issues pertaining to spurious drugs.
Bureau Report
The Drug and Cosmetics Act should be suitably amended and the maximum penalty for sale and manufacture of spurious drugs causing grievous hurt or death enhanced from life imprisonment to death, the committee said in a report, presented to Health Minister Sushma Swaraj today. The government should also make the penalties more deterrent for other related offences, the report said.
Calling for effective deterrence against offenders at the investigation level itself, the report said a specific provision in the Drugs and Cosmetics Act would allow persons indulging in spurious drug offences to be detained for a minimum period.
There is a need to make a distinct provision in the DCA itself declaring all offences related to spurious drugs as cognizable and non-bailable, the report said. It is necessary to involve police authorities in addition to drugs inspectors and authorise them to file prosecutions for spurious drugs under the Drugs and Cosmetics Act, it said.
Noting that most of the cases relating to spurious drugs remained undecided for years, the committee suggested a separate provision for speedy trials of such offences.
Regretting that the level of enforcement of the Drugs and Cosmetics Act, in existence for the past 56 years, was "far from satisfactory", the committee said though the idea for setting up of a National Drug Authority (NDA) had been reiterated many times, it was not implemented.
The existing infrastructure at the central and states was not adequate to perform the assigned functions efficiently and speedily, it said.
However, creating another authority would not solve the problem, it said adding it was essential to strengthen the existing organisations to enable them to undertake all the functions envisaged for NDA. "A strong well-equipped and professionally managed CDSCO, which could be given the status of Central Drug Administration (CDA) was the most appropriate solution," the committee said.
As the onus of monitoring drug manufacturing standards, drawing and testing of samples and taking legal action against infringes rested with state drug regulatory agencies, it was essential that the state governments strengthen and support their drug control organisations, the committee said.
The problems of fake drugs were also due to inadequate testing facilities, shortage of drug inspectors, non-uniformity of enforcement, lack of specially-trained cadres for specific regulatory areas, non-existence of data bank and non-availability of accurate information, it said.
Despite several directions from the central government, many state governments are yet to upgrade the drug testing facilities, it said.
According to the information received from 26 states/union territories, only 15 drug testing laboratories are functioning. Out of these only seven were reasonably equipped and the rest didn't even have bare minimum equipment.
The committee also recommended a scientifically and statistically valid study to evaluate and quantify the extent of the problem of spurious drugs at various levels in the supply chain at the regional and national levels. The government should provide the funds for the study which should take place at the earliest.
Stating that responsibility for effective management of the issue of spurious drugs also came to medical and para-medical professionals, pharmaceutical companies, patients, media, distributors, it said the industry and trade associations should play a more active and collaborative role to arrest the menace.
The government had decided the committee under the chairmanship of Dr R A Mashelkar to examine all issues pertaining to spurious drugs.
Bureau Report