In December last year, Finance Minister Nirmala Sitharaman hailed India as the “Pharmacy of the World”, owing to its high and efficient production of “global standard medicine” at affordable costs. However, that image suffered considerable damage following allegations of sub-standard or contaminated drugs exported to countries like Gambia and Uzbekistan.
To “ensure that the regulatory mechanisms of the country are of impeccable standards and are sustained over time and space”, the Centre has begun a series of chintan shivirs or thought meets with 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 to be discussed at the Hyderabad conclave include having a centralised drug registration system under the Central Drugs Standard Control Organisation (CDSCO) to keep close tabs on the quality of drugs produced.
Union Health Minister Mansukh Mandaviya inaugurated the two-day chintan shivir on Drugs: Quality Regulations & Enforcement organised by the Ministry of Health in Hyderabad on Sunday.
In Assam’s Kaziranga National Park, another two-day chintan shivir organised by the Ministry of AYUSH will commence on Monday.
Mandaviya 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.”
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Minister of State for Health and Family Welfare Bharati Pravin Pawar, Minister of State for Chemicals and Fertilizers Bhagwanth Khuba, and Member (Health) of NITI Aayog V K Paul 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 a meeting on such a grand scale spearheaded by the Union health minister has been organised. For the first time, ground-level officers get a chance to offer their suggestions to the minister in person,” said a senior government official.
Discussions on stricter enforcement, better training, regular capacity upgrades, uniform standards, building a culture of compliance, maintaining supply-chain security, integrity, transparency, accountability, and predictability will take place, the official added.
Discussions on stricter enforcement, better training, regular capacity upgrades, uniform standards, building a culture of compliance, maintaining supply-chain security, integrity, transparency, accountability, and predictability will take place, the official added.
The idea is to address issues that exist within the network, and actions that can be taken to build confidence in the quality of drugs made by India for the world.
One of the key proposals to be deliberated upon at the two-day Hyderabad conclave is whether it is time to have a central drug registration system or a common information technology (IT) platform for all regulatory activities.
The intent is to create a centralised system of drug registration under CDSCO, unlike the current system of state-level registrations. This will help to keep a closer watch on the quality of medicines produced in India.
Currently, several pharmaceutical companies get registration from state food and drug administrations to manufacture these drugs. 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, any manufacturer can seek a licence to manufacture it from the state regulator. In this case, no dossier approach is followed.
Industry experts have said that India’s fragmented regulatory system is a major challenge to procurers. “The manufacturers change the source of the active pharmaceutical ingredients or even excipients. These crucial changes are not necessarily reported to the state regulator,” said an industry insider.
The health ministry in a statement said that the participants will be discussing matters like the creation of a unified IT platform for all regulatory activities; to assess regulatory capacity across states and the Centre, along with promoting the ease of doing business; and capacity building at the level of states and national regulator for the regulation of pharmaceutical and medical devices.
Meanwhile, the Ministry of AYUSH’s chintan shivir in Assam will focus on dialogues to discuss futuristic improvements in the implementation of existing policies and programmes related to AYUSH sectors and traditional medicine. It aims at drawing up 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, start-ups, academia, apart from interactive sessions with other AYUSH stakeholders.
