The drug regulator has revoked the licences of several pharmaceutical enterprises operating in about 20 states nationwide due to concerns expressed by numerous public health experts and even certain pharmaceutical manufacturers regarding the prevalence of substandard quality medicines in the nation. According to sources, a large-scale campaign against attempts to manufacture fake or inferior pharmaceuticals in the nation has been underway. A seminar on increasing medicine quality was previously held by the health ministry in Hyderabad. During this meeting, several topics linked to guaranteeing the quality of pharmaceutical products were thoroughly discussed. The ministry has also hinted that it will take enforcement action against medicine makers who produce subpar or fake products.
According to reports, at least 18 pharmaceutical enterprises had their licences revoked for producing fake medications as a result of the inspections conducted in more than 70 manufacturing facilities across states under the direction of the Drugs Controller General (India) (DCGI). Also, the action against 70 businesses in Himachal Pradesh and about 45 units in Uttarakhand—two key centres for pharmaceutical manufacture that serve a sizable portion of the domestic pharmaceutical markets—has been the result of the move. Also, as part of the inspections, action has been taken against more than 20 enterprises in Madhya Pradesh.
After reports of deaths linked to the usage of cough syrups made by these companies in Uzbekistan and the Gambia, the State and the Central Licensing Authorities recently issued directives to Noida-based Marion Biotech and Haryana-based Maiden Pharma. The excipient propylene glycol supplied by Delhi-based Maya Chemtech India Pvt Ltd has also been warned not to be used by the States and Union Territories by the Union Ministry of Health and Family Welfare because it allegedly does not conform to IP 2018, addendum 2021 in terms of identification and is not of standard quality. Ethylene glycol was discovered to be present in the company’s sample, it continued.
It should be mentioned that the ministry of health recently conducted a two-day brainstorming conference on drug quality rules and enforcement in light of the quality difficulties that have surfaced with medications made in India both domestically and internationally. The discussions, according to the Union Ministry of Health and Family Welfare, one of the event’s organisers, focused on how to implement uniform standards, strong compliance and enforcement mechanisms, and capacity enhancement to make the nation’s drug regulatory systems transparent, dependable, and verifiable.
Technology was also shown to have the potential to facilitate and promote accountability, transparency, and standardisation. It further stated that the requirement for an unified portal with a national database and connected legacy systems was explored. Global benchmarking for both medications and medical devices, as well as the transition from minimal to optimal standards with the availability of periodic reviews, were discussed during the conclave. A number of participants emphasised the significance of developing citizen-facing policies to boost consumer confidence in the quality of drugs, along with complaint portals, successful recall procedures, etc.
For quality assurance, it was also suggested to monitor the supply chain. The state health representatives highlighted best practises for drug regulation from different states in order to give a platform for learning from other states’ experiences. “It is imperative to guarantee that the pharmaceuticals and healthcare goods made in India are of the greatest calibre for both domestic and international markets. In order to ensure the establishment of strong regulatory systems, the Center and States must cooperate harmoniously and synergistically within the framework of the nation’s Federal Democratic structure, said Union Minister of Health & Family Welfare and Chemicals & Fertilizers Dr. Mansukh Mandaviya at the closing session of the conclave on “Drugs: Quality Regulations & Enforcement,” held in Hyderabad.
According to Dr. Mandaviya, the Chintan Shivir’s deep dive sessions gave all stakeholders a forum to discuss many facets of constructing a strong, resilient, transparent, responsible, and citizen-friendly pharmaceuticals regulatory framework. The finest quality pharmaceuticals and medical devices will be easily accessible and available across the nation thanks to this framework, he continued.
