The Narendra Modi government has formed a panel to frame new laws for medicines, cosmetics and medical devices, News18.com has learnt. The newly formed eight-member panel, headed by the drug controller general of India, VG Somani, will submit the draft document by November 30.
According to India’s apex regulatory body, Central Drugs Standard Control Organisation (CDSCO), the Drugs and Cosmetics Act, 1940 regulates the import, manufacture, distribution and sale of drugs and cosmetics. Recently, it was amended to add medical devices.
According to the internal order, accessed by News18.com, “The government has decided to constitute a committee for framing/preparation of New Drugs, Cosmetics and Medical Devices Bill so that New Drugs, Cosmetics and Medical Devices Act can be framed.”
The other members of the panel include Rajiv Wadhawan (director, Ministry of Health and Family Welfare), Dr Eswara Reddy (joint drug controller), AK Pradhan (joint drug controller), IAS officer NL Meena followed by drug controllers of Haryana, Gujarat and Maharashtra.
“The committee shall undertake pre-legislative consultations and examine the present Act, previously framed Drugs and Cosmetics Bills and submit a draft document for a de-novo Drugs, Cosmetics and Medical Devices bill,” said the order dated 27 August. The order is titled ‘Constitution of Committee for Framing of New Drugs, Cosmetics and Medical Devices Act’.
New Act is the need of an hour: Industry
In 2020, the Ministry of Health and Family Welfare had brought medical devices within the regulatory ambit, treating them as a category of ‘drugs’ for the purpose of regulation.
According to the pharmaceutical industry experts, a new Act is the need of the hour. “The Act is completely obsolete as it was formed in 1940. Since 1940, it has undergone multiple amendments. It has now become very confusing and unclear for the industry,” said an official representing a lobby group of top pharmaceutical companies.
“If the government has started the process now, it will take at least one year to notify the new law as the draft will first go to Lok Sabha, Rajya Sabha and then to the President.”
Another official representing a pharmaceutical firm said, “The act doesn’t talk about anything latest. For instance: It does not allow online sales of medicines as it dates back to the pre-Independence era. We need the latest act immediately.”
However, industry experts pointed out that the panel must contain officers from several other fields. “This is a huge conflict of interest to create such a committee without representation from other stakeholders like manufacturers, doctors, academia, scientists and consumer or patient bodies,” said Rajiv Nath, forum coordinator, Association of Indian Medical Devices Industry.