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AIDCOC objects to proposed bill to centralize drug licensing

A Raju, Hyderabad
Tuesday, August 6, 2013, 08:00 Hrs  [IST]

The All India Drugs Control Officers' Confederation (AIDCOC) is gearing up to oppose the proposed central drug control administration bill in parliament as the confederation feels that it will curtail the powers of state drug controllers and moreover delay the licensing system in the country.

According to Ravi Uday Bhaskar, secretary general, AIDCOC, the central drug standard control organisation (CDSCO) is trying to centralize the entire drug licensing system by curtailing the powers of the state DCAs and asked the rationale behind such a move when the state drug authorities are equally competent enough to do the job. When the world is moving towards decentralization for better governance and transparency, the CDSCO proposal to centralize the authority is unwarranted.

Voicing strongly against the proposed bill, the AIDCOC general secretary said, “Health is in the concurrent list and it is the subject of both the state and central governments and therefore both are equally empowered to give licenses or cancel the approvals. Limiting the powers of state DCAs is unacceptable. We are mobilizing all the state DCAs and will speak to the health ministry and others at central government and fight for our rights.”

With the bill being cleared by the central cabinet, AIDCOC and the state drug control administrations across the country are totally opposing the government’s move to pass the bill in the parliament. “We are totally against the proposed bill to set up a central drug authority. If the bill is passed, it will curtail the powers of state DCAs and the CDSCOs will intrude into the affairs of the SDCAs which is not at all acceptable,” pointed the secretary.

As the bill has already been cleared by the union cabinet, the health ministry is planning to introduce the same during the upcoming session. The Drugs and Cosmetics (D&C) Bill, 2013, is a comprehensive legislation for the drugs and cosmetics sector and it aims to build a centralised drug control system on lines of US FDA.

As per the provisions of the bill, it is proposed to introduce separate chapter on clinical trials and another on medical devices. Earlier the bill was amended in 2008 but did not have separate chapters on clinical trials and medical devices regulations which lay down specific penal provisions in case of any violation. The bill also proposes set up a Central Drugs Authority (CDA) to act as an appellate body for central and state drug controllers. As per the new bill the CDA will be the only authority to issue manufacturing licenses covered under 17 critical categories, which was earlier issued by the state DCAs.

“It is nothing but an attempt to centralize the drug licensing system and to curtail the power of state drug control authority. Intruding into the affairs of state drug control administration will not only dilute the entire system but also delay the process of licensing which is already been hit hard,” said Raja Bhanu, assistant drug controller, APDCA.

While pointing at the inefficiency of CDSCO officials,AIDCOC general secretary said, “Already the parliamentary committee has pointed against the CDSCO for granting manufacturing and sales permission to 33 drugs without conducting phase-II trials in the country. This reflects the inefficiency of the CDSCO officials. The CDSCO needs to take steps to recall all the 33 drug approvals and investigate against the officials who have granted license.”

“We demand the central drug control administration to strengthen the state DCAs by empowering them with additional manpower and equipping them with required infrastructure and enable them to enhance updated knowledge and information about advanced technology, procedures and regulations to contain spread of spurious drugs. The CDSCOs main objective should be to monitor and supervise the state DCAs and leave the job of licensing to the state DCAs,” another senior drug control official of AP drug control association said.

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