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Severe doses prescribed to check spurious drugs

The Mashelkar Committee, looking into the menace of spurious drugs, proposes death penalty as one of the ‘‘more deterrent measures...

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The Mashelkar Committee, looking into the menace of spurious drugs, proposes death penalty as one of the ‘‘more deterrent measures’’ needed to check the manufacture and distribution of such drugs.

In its interim 43 page report — it will be submitted to Health Minister Sushma Swaraj after a final meeting scheduled for Monday — the panel, noting that ‘‘severe’’ and ‘‘sure’’ punishment can be the only deterrent, suggests amendments to the Drugs and Cosmetic Act.

‘‘Apart from penalties of fines and imprisonment for life specifically in those cases which had resulted in grievous body harm or loss of life, death penalty was required to be provided.’’

The prescription

• Death penalty or life term for spurious drug manufacturers

A Central Drug Administration to handle manufacturing licences

• States to licence sales outlets and monitor quality

Designated officer in each state trained in investigating drugs

• Additional manpower to states for proper surveillance

The committee has also called for a special provision in the Act which will ensure people behind spurious drugs don’t get away so lightly: there will be a minimum period which will have to be spent in detention.

Considerable emphasis has also been laid on the need for a provision in the Act which declares all offences related to spurious drugs as cognisable and non-bailable.

Maintaining that the existing infrastruture at the Centre and states was not adequate to perform assigned functions efficiently and speedily, the committee, while ruling out the creation of another authority like National Drug Authority, wants the existing infrastruture empowered better.

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The committee has suggested the status of a Central Drug Administration (CDA) for the Central Drugs Standard Control Organisation (CDSCO). Although a detailed proposal is likely to be made in the final report, the committee wants the CDA made a Central drug licensing authority.

The states, the panel feels, should provide licenses to sales outlets and monitor the quality of drugs. This will allow states to be reasonably focused on detection and investigation of spurious drugs.

Each state should have a designated officer trained in investigation of spurious and counterfeit drugs. There also should be a Central nodal officer to establish a countrywide network.

The committee also recommends additional manpower for states to set up intelligence-cum-legal cells under trained staff for a proper surveillance system. Another proposal is to have a board to advise the Drugs Controller General of India on testing. Units of DCGI should draft disease-wise testing protocols for drugs.

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Dismayed that most prosecution cases pertaining to spurious drugs remain undecided, the committee has recommended involvement of the police, in addition to drug inspectors, at an early stage of investigations so that cases of spurious drug offences under the Drugs and Cosmetic Act can be registered.

The report lists ‘‘inadequate and weak’’ drug control infrastructure at the state level as a major problem in the regulatory system.

‘‘The level of enforcement in many states is far from satisfactory. Inadequate testing facilities, shortage of drug inspectors, non-uniformity of enforcement, lack of specially trained cadres for specific regulatory areas, non-existent data bank and non-availability of accurate information were the main reasons for this less than satisfactory performance.’’

‘‘Out of 26 states/ UTs, only 15 drug testing laboratories are functioning. Of these, only seven were reasonaly equipped/staffed while the others were poorly staffed and did not even have the bare minimum equipment,’’ states the interim report.

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The committee noted that the extent of the menace of spurious drugs has been quoted between 0.5 to 35 percent by various sources. With no concrete picture emerging, the committee has recommended that a scientifically and statistically valid methodology be launched to evaluate and quantify the extent of the problem of spurious drugs.

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