People's Democracy

Drugs And Cosmetics (Amendment) Bill, 2007

Oppose This Harmful, MNC-Friendly Legislation

J S Majumdar

HERE is another example of central government�s attempt to encroach upon state government�s rights through the Drugs and Cosmetics (Amendment) Bill, 2007. The Bill is now pending before the parliament.

The statement of �Objects and the Reasons� of the Bill states, �The central government had constituted an expert committee under the chairmanship of Dr R A Mashelker, director general of the Council of Scientific and Industrial Research (CSIR) in January 2003 to undertake a comprehensive examination of drug regulatory issues, including the problem of spurious drugs and to suggest measures to improve the drug administration in the country. The committee, inter alia, recommended setting up of a Central Drugs Authority reporting directly to the ministry of health and family welfare and a system of centralised licensing. The central government considered the recommendations of the committee and proposes to make amendments in the Act, in order to facilitate setting up of a Central Drugs Authority and introduction of centralised licensing for manufacture of drugs in pursuance of the said recommendations.� (emphasis added)

The same Dr R A Mashelker headed the government�s committee on patents. He had to withdraw his report on Patents when it was revealed that his report was virtually copied from a report prepared in London by multinational drug firms like Novartis and other companies and funded by them. Novartis challenged Indian Patent (Amendment) Act in Madras High Court questioning the right of Indian parliament to make such amendments which are in variance with WTO agreement on intellectual property rights. The CPI(M) played a big role, both inside and outside parliament, in safeguarding our national interests during the amendements to the Patents Act.

Proliferation of spurious or fake drugs is of serious concern. The drug control machinery under the government completely failed to check this menace despite sufficient powers under existing law. The issue was raised repeatedly in the parliament. But, the Bill neither contains any clause to check manufacturing and selling of spurious drugs nor there is any deterrent clause providing stronger punishment for these. The Bill only proposes central licensing. How central licensing is going to check proliferation of spurious drugs is beyond anybody�s comprehension. Do the spurious drugs manufacturers and sellers require drug license?

The main purposes of the Bill are �introduction of central licensing.� and �setting up of a Central Drug Authority�.

Under existing laws, it is the state governments which issue licenses for manufacture and sale of drugs. This Bill proposes to take over the drug licensing right from the state government and hand it over to the central government. If this amendment is passed by the parliament and drug licensing is centralised, thousands of small and medium sector drug manufacturing companies all over India will not be able to get their licenses and will be forced to close down; thousands of workers will lose jobs, and the self-employed will be deprived of their livelihood. Moreover the state governments will face difficulties in procurement of generic medicines and their health programmes will be seriously affected. Multinational and big companies will be monopolising the drug market. That is the reason as to why the Organisation of Pharmaceutical Producers of India (OPPI), the association of multinational drug firms, immediately came out in support of this Bill.

The other Object and Reason in the Bill is �setting up of a Central Drugs Authority� (CDA). In this regard the Bill states, �The Central Drugs Authority shall consist of a chairperson and not more than five, but at the least three, members, to be appointed by the central government by notification in the Official Gazette.� And who should be the chairperson and members? The Bill states, �The chairperson and members of the Central Drugs Authority shall be appointed by the central government from amongst persons who have special knowledge of, and at the least fifteen years� professional experience in pharmaceutical industry, etc.� Through this clause in the Bill there is enough scope for drug industry men to become chairperson/members of CDA.

The whole purpose of the Bill is to hand over the Central Drugs Authority to MNCs and big drug companies. They will �issue licenses under clause (c) of section 10, clause (c) of section 18� of the Act; �suspend any license issued;� �granting permission for conduct of clinical trials in respect of drugs and cosmetics;� �regulate manufacture for sale or for export or for distribution, or sale, stock or exhibition of drugs and cosmetics;� �regulate import of drugs and cosmetics;� etc and �shall regulate its own procedure.�

Not only that, �The Central Drugs Authority shall appoint a Drugs Controller (India), and such other officers and employees as it considers necessary for the efficient discharge of its functions and exercise of its powers under this Act.� And �The Drugs Controller (India) shall exercise the powers conferred upon him under this Act or the rules framed thereunder or assigned to him by the Central Drugs Authority.�

Today, the Drug Controller General (India) functions under the jurisdiction of the ministry of health and family welfare of the government of India. If the Bill is passed he will be acting as per dictates of drug industry.

The implications of the Bill are far reaching. It also raises the question on the future role of the State drug control mechanism; the licensing and control on drug distribution and sale etc. The critical area of outsourced clinical trials will be in the hands of CDA controlled and directed by drug companies. It will seriously affect national and states� health programmes.

This Bill needs to be opposed both inside and outside the parliament.