AN expert committee appointed by the Union government in January 2003 under the chairmanship of former Director General of the Council for Scientific and Industrial Research (CSIR) R.A. Mashelkar to examine all aspects of the regulatory infrastructure and the problem of spurious and substandard drugs presented its report in November 2003. The report underscored the need for changes in the law to provide enhanced penalties and make the offences cognisable and non-bailable, in the light of similar provisions in the Narcotic Drugs and Psychotropic Substances Act.
It called for steps to amend the Drugs and Cosmetics Act suitably and enhance the maximum penalty for the sale and manufacture of spurious drugs causing grievous hurt or death from life imprisonment to death. Likewise, the government should make the penalties more deterrent for related offences, it said.
Referring to the situation that prevailed then, the committee noted in its report that the level of enforcement of the Drugs and Cosmetics Act in many States had been far from satisfactory. The non-uniformity in the interpretation of the provisions of laws and their implementation and the varying levels of competence of the regulatory officials were the main reasons for this less than satisfactory performance, it pointed out.
The committee concluded that the problems in the regulatory system in the country were because of inadequate or weak drug control infrastructure at the State and Central levels; inadequate testing facilities; shortage of drug inspectors; non-uniformity of enforcement; lack of specially trained cadres for specific regulatory areas; non-existence of a data bank; and the non-availability of accurate information.
The report categorically said that the existing infrastructure at the Centre and in the States was not adequate to perform the assigned functions efficiently and speedily. It also suggested that a strong, well-equipped, empowered, independent and professionally managed Central Drugs Standard Control Organisation, which could be given the status of Central Drug Administration and which reported directly to the Ministry of Health, would be the most appropriate solution.
The committee called for urgent steps to strengthen the State drug control organisations with competent and trained manpower, besides earmarking adequate funds. It also made several recommendations to the States to tackle the problem of spurious drugs. Some of them were ensuring effective interaction among the stakeholders such as industry, regulators, consumers, trade, and medical professionals; setting up of intelligence cum legal cells in State and Central offices; discouraging proliferation of drug distribution outlets; and designation of special courts to try cases of spurious drugs.
Among the other recommendations are preparing dossiers of suspected dealers and manufacturers; providing secret funds and incentives to informers; creating an effective networking system among States; checking on drug supplies to practitioners who buy and supply drugs to their patients; creation by the industry strategies to tackle counterfeit drugs; working out a better surveillance system and an efficient complaint handling system; and spreading awareness among consumers.
The discovery of fake and time-barred drugs in Tamil Nadu makes it clear that little has moved in the State in the direction of implementing the recommendations.
S. DorairajCOMMents
COMMents
SHARE