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ODCOA wants Centre to make amendments in New Drugs Bill 2022 as per provisions of Indian Constitution
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Peethaambaran Kunnathoor, Chennai
August 29 , 2022
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Disagreeing with several provisions in the draft New Drugs Bill 2022, the Odisha Drugs Control Officers Association (ODCOA), through a letter to the under-secretary of the union ministry of health and family welfare, says that the revision and amendment of the drug regulation laws should not be biased against the states who are obliged to implement any act.
According to them, any amendment of a provision in the act has to be made as per provisions of the Indian Constitution as drugs are coming under the concurrent list.
ODCOA further alleges that, as per the draft, the sole authority to approve or grant of license is the Central Licensing Authority (CLA) or the DCGI, which is violative of Article 73 and Article 256 of the Indian constitution which state that ‘every state shall utilize its executive powers in conformity with the laws made by the Parliament and with all the pre-existing laws prevailing in the state’.
The drug regulatory officers argue the central government should make the rules for uniform implementation by states, but it cannot become a parallel authority with commanding powers to the central government over states to implement the act. ODCOA feels that the constitution of the country does not support such a provision giving powers to dual control in a subject of the concurrent list. If such an authority is created it will take the powers of the states and concentrate it with the centre. Ultimately the people will suffer a lot due to delays in the disposal of work which will encourage corruption.
The officers observe from current experience that there is a clash of interest and chance of corruption and malpractices in the way the regional drug testing labs (RDTL) and the central drug testing lab in Kolkata are working because of absolute power vested on the DCGI. They invited the attention of the authorities to the earlier two incidents that the Central government had in 2003 and in 2007 made attempts to take the powers of the states in drug regulations by bringing bills in the Parliament, but could not succeed as the legislative body declined them.
The letter signed by the association president Dr. Sudarsan Biswal and the general secretary Chandan Kumar Giri points out that there is no provision for the state governments to notify any chapter or any provision in the draft bill whereas drugs are on the concurrent list of the constitution. So it is obligatory on the state government to implement the legislation as per Article 256 of the constitution. Talking to Pharmabiz Dr. Biswal said without notification a state cannot be responsible for implementation of a bill to prohibit manufacturing and sale of spurious, adulterated and substandard drugs.
Further ODCOA suggests that there should be a law to prosecute and punish the manufacturers of APIs if the active pharmaceutical ingredients are found to be of less quality. This will ensure the quality of the APIs used for formulation making and thereby the quality of all finished products can be assured. Provisions are needed for prosecution under Section 18 and for punishment under Section 27 similar to those for the production of formulations.
ODCOA strongly opposes inclusion of marketers and promoters of pharmaceutical products under the ambit of manufacturer and says that it is illegal and unconstitutional, and also against the provisions of natural justice. “A manufacturer is granted a separate license to manufacture the drugs, whereas the marketer is granted a wholesale license to sell and distribute the drugs produced by an independent manufacturer. One wonders how legislation can be forcibly placed on a marketer to detain him for an activity which he has no role to play in and not involved in any manner,” says Chandan Kumar Giri, secretary of the association.
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