New Delhi: The government works to bring new laws to regulate drugs, cosmetics and medical devices in accordance with changes in pharmaceutical markets making existing laws inadequate to monitor new retail roads and demands of regulations that have emerged in recent years.
The proposed new law will replace existing drugs & cosmetics, 1940 and will comprehensively overcome fields such as medical devices, hospital equipment, e-pharmacies, authorization of emergency use and compensation norms in the case of eUAS and an official said.
The Ministry of Health has formed a committee to examine the existing law and propose a draft for new law on November 30.
The eight member panel was led by the drug controller General India (DCGI) with a representation of various state drug regulators and the Ministry of Health.
“The Committee must conduct a previous consultation and examine this action, previous framed drugs & cosmetic bills and submit draft documents for drugs de-novo, cosmetics and medical device bills of 30,11,2021,” said the Ministry of Health in the details of the order.
Reference panel requirements.
Toi has reviewed the order.
At present, drug law and cosmetics, 1940 regulate import, manufacturing, distribution and sale of drugs and cosmetics.
Through the recent amendment, the law enters medical device regulations as well.
However, this provision is limited to regulating a rapidly growing segment that has advanced and innovative products entering the market.
A committee under Niti Aayog previously suggested a separate law to regulate medical devices.
While the proposed new law is expected to regulate various regions that are still not handled in existing laws, this industry holds that all stakeholders must be represented in the Committee.
Medical device manufacturers also urge the government to have separate laws for regulating medical devices, which are different from drugs.
“Draft Niti Aayog 2019 from a separate bill to set the device is in the right direction.
Such confusing signals confuse potential investors Medical devices and India will still depend on one step forward two steps back move” Rajiv Nath, Forum Coordinator, which is intended, which represents the manufacturer of local medical devices.