House panel sitting on Central drugs authority today

Staff Reporter

Thiruvananthapuram: The Parliamentary Standing Committee on Health and Family Welfare, which is in the process of examining the Drugs and Cosmetics (Amendment) Bill 2007 for setting up a Central Drug Authority of India (CDAI), is holding its sitting in the capital on January 9 and 10.

The committee, which has P.J. Kurien and Pannian Ravindran, MP, representing the State, will also be examining the Clinical Establishments (Registration and Regulation) Bill, a Central legislation proposed by the Centre to ensure uniform standards for the facilities and services offered by clinical establishments, including clinics run by single doctors.

The proposed Central Drug Authority will be an autonomous organisation under the Union Ministry of Health and Family Welfare and is envisaged on the lines of the Food and Drug Administration (FDA) in the United States.

At present, drug manufacturing licences are issued by various State drug control authorities and there is a lack of coordination between the State and Central authorities which has made it very difficult to keep track of the drug licences being issued in various places across the country.

The CDAI is expected to ensure that drug manufacturing licences are issued only by one Central agency.

It will also have ten separate divisions to deal with new drugs and trials, for biologicals and biotech products, pharmacovigilance and drug safety, medical devices and diagnostics, quality analysis etc.

State’s concerns

The State Health department, which will be making its representations before the committee, expressed apprehensions over the fact that the CDAI may not have the full law-enforcing powers of a proper department.

The CDAI should not remain a mere licensing authority, while law enforcement will again be the State’s responsibility, it is pointed out.

The State’s drug control department has at present all law enforcing powers. The setting up of the CDAI should not rob the State of its enforcing powers and instead should be equipped with more resources and manpower to implement drug control laws strictly, the Health Department feels.

The State stands to lose all licensing fee once the manufacturing and sales licences are issued by the Centre.

Another suggestion that the State may put forth is that rather than set up a central agency, the current system of drug licensing should be tightened and made uniform across States.

With the enactment of this Central legislation, all clinical establishments, including diagnostic centres, will be registered and regulated by the National Council of Standards, which will prescribe minimum standards for healthcare services and maintain a national register of clinical establishments. It has also proposed the accreditation of healthcare firms.

As health is a State subject, the proposed Bill will have to have the State’s approval.

Separate Act

The Health Department officials said that the State government has decided to formulate a State Act to accredit private hospitals. Even though the proposed Kerala Private Health Care Institutions Council Bill 2006 is before the government, it has now been decided that rather than a ‘council’, an agency with more teeth is required.