As India, the so-called pharmacy of the world, battles allegations of sub-standard or contaminated drugs exported to countries like Gambia and Uzbekistan, the Centre has begun a series of ‘chintan shivirs’ or discussion meetings of the country’s top drug regulators, senior government policy officials, industry representatives and stakeholders to deliberate on pathways for cohesive and synergistic approaches for building robust and resilient regulatory systems.
Proposals such as having a centralised drug registration system under the Central Drug Standard Control Organisation (CDSCO) to have a closer watch on medicine quality are likely to be discussed during the Hyderabad conclave.
Union Health Minister Mansukh Mandaviya inaugurated the two-day ‘chintan shivir’ organised by the Health Ministry in Hyderabad on Sunday. In Assam’s Kaziranga National Park, another two-day ‘chintan shivir’ organised by the Ministry of Ayush will start on Monday.
The Health Minister highlighted that “it is of critical importance to ensure that the regulatory mechanisms of the country are of impeccable standards and are sustained over time and space. This is possible when the Central Ministries and state bodies work in a spirit of cooperative federalism, building on the strengths of one another and working jointly to remove loopholes in the regulatory systems.”
Bharati Pravin Pawar, Minister of State for Health and Family Welfare, Bhagwanth Khuba, Minister of State for Chemical and Fertilisers, and V K Paul, Member (Health), NITI Aayog, participated in Sunday’s brainstorming session in Hyderabad. Health secretaries and drug regulators from various States and union territories are also participating in the two-day meetings that are bringing together regulators and top government officials on a common platform to discuss important issues of the pharmaceutical industry.
“This is the first time that a meeting of this scale has been organised, and headed by the Union Health Minister. For the first time ground level officers get a chance to give their suggestions to the minister himself. The Minister is in a listening mode and very in-depth discussions have happened,” a senior government official said.
Discussions on stricter enforcement, better training, regular capacity upgrades, uniformity of standards, building compliance culture, maintaining supply chain security, integrity, transparency, accountability and predictability are happening at the conclave, the official added. The idea is to address the issues that exist in the network, and actions that can be taken to address them to build confidence in the quality of drugs made by India for the global markets.
One of the key proposals to be deliberated upon in the two-day Hyderabad conclave is whether it is time to have a central drug registration system or having a common IT platform for all regulatory activities. The idea is to create a centralised system of drug registration under the CDSCO, unlike the current system of having state-level registrations. This will help to keep a closer watch on the quality of medicines produced in India.
Currently, several pharma firms get registered to make these drugs by state food and drug administrations, and eventually, these drugs are sold across the country. The CDSCO has a dossier approach for each drug it approves at the central level. However, when a drug becomes older by more than four years or so, then any manufacturer can seek a license to make it from the state regulator. In this case, no dossier approach is followed.
Industry experts have said India’s fragmented regulatory system is a major challenge for procurers and quality assurance. “The manufacturers change the source of the active pharmaceutical ingredients (APIs) or even excipients, and these key changes are not necessarily reported to the state regulator,” said an industry insider.
The Health Ministry said in a statement that the participants will be discussing on matters like creation of a unified IT platform for all regulatory activities; to assess regulatory capacity across the States and Centre along with to promote ‘Ease of Doing Business’; and capacity building at the level of the States and National Regulators for regulation of pharmaceuticals and medical devices.
Meanwhile, the Ayush Ministry ‘chintan shivir’ in Assam is focusing on dialogues to discuss futuristic improvements in the implementation of existing policies and programs relating to Ayush sectors and traditional medicine. It aims to chalk out a way forward—both for the Ministry and the Ayush sector as a whole.
The two-day dialogue will have panel discussions with eminent speakers and experts from the Ministry of Ayush, Ministry of Health and Family Welfare, Ministry of Education, Government of Assam, NITI-Aayog, industry, startups, academia, etc, apart from interactive sessions with the other Ayush stakeholders.
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