Will 2025 see a more vigilant government when it comes to violations by pharma companies, be it GMP slip ups or the Uniform Code of Pharmaceutical Manufacturing Practices (UCPMP)?
For instance, time is running out for MSME pharma companies, as we pass the December 31 deadline to comply with the revised Schedule M of the Drugs and Cosmetics Act.
While this segment of pharma companies, a turnover of less than Rs. 250 crore, was given an extra six months to comply with these revised rules, industry insiders comment that even most larger companies have not yet fully complied with all requirements of the revised guidelines.
Multiple industry associations representing MSME pharma have approached the authorities to extend the deadline for them to complete upgrading their facilities but so far there has been no response. The word is that the government will have no choice but to extend the deadline to avoid the shuttering of non-compliant factories which might lead to shortages. The ensuing job losses and dip in state revenues will also play a role in this decision.
Sources also indicate that the regulatory authority government too needs more time as there are many drug inspector posts still vacant. This clearly means that even if there is no extension of the December 31 deadline, it would be some time before inspections can be rolled out. This lacuna was highlighted during the ongoing parliamentary session, when the fifth report of the Parliamentary Standing Committee on Chemicals and Fertilisers presented to the Lok Sabha during this session, mentioned that as of last December, almost 60 per cent of the sanctioned strength of drug inspectors, which is 303 out of the total 504 posts, were vacant.
The Committee has urged the centre to fill up these vacancies on priority as well as assess the need to sanction more posts, considering that the country has more than 750 districts. The fifth report cited the need “to ensure effective regulation and oversight owing to the multifaceted issues grappling the spurious/NSQ drugs”, noting that “as on date only 5.9 per cent (only 35 convictions) of the total 593 cases relating to spurious/adulterated drugs have been resolved, with the remaining cases at various stages in respective courts.” While there have been reports of plans to recruit 250 drug inspectors, the health ministry clearly needs more time.
Secondly, consider the Department of Pharmaceuticals’ action on an anonymous complaint that AbbVie Healthcare India had violated the Uniform Code of Pharmaceutical Manufacturing Practices (UCPMP).
According to the December 23, 2024 order of the Apex Committee for Pharma Marketing Practices of the Ministry of Chemicals & Fertilizers Department of Pharmaceuticals, the complaint provided proof that the company ‘provided travel tickets and hotel accommodations for extravagant pleasure trips under the guise of conferences’ (Aesthetics & Anti-Aging Medicine World Congress 2024), which took place from February 1 to 3, 2024, and from March 26 to 29, 2024, in Monaco and Paris, respectively, for 30 doctors connected to the medical aesthetics/ anti-ageing products (Botox and Juvederm).
After audits and hearings, the DoP has asked for the reprimand to be posted on the pharma company’s website and will be evaluating the tax liability of AbbVie Healthcare India along with 30 HCPs and take action in accordance with the provisions of the Income Tax Act, 1961. Thirdly, the Apex Commitee has requested the National Medical Council (NMC) to take action against the 30 offending HCPs as per Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002.
The government’s tough stance on UCPMP, possible GMP inspections and the upcoming Union Budget will see pharma companies hoping to influence DoP officials. For example, industry lobby groups reportedly met government officials to give their suggestions on guidelines for over the counter (OTC) medicines. The government is reportedly mulling a list of medicines which can safely make the switch from prescription (Rx) to OTC. Though these medicines are already freely available without prescriptions in most pharmacies, the official Rx to OTC switch will allow them to be sold in groceries stores as well. Online pharmacies too will benefit from more Rx medicines the switching to OTC.
While the Rx to OTC switch will improve access, there is already rampant use of many such medicines. The lack of awareness on the potential overuse and misuse of OTC medicines, thanks to low literacy levels and multiple languages in India, is a serious concern. Can government officials ensure that while making the Rx to OTC switch, there are adequate awareness campaigns, highlighting the proper use of such medicines to prevent misuse?
Will the ruling in the AbbVie Healthcare India case prevent future violations of the UCPMP? Is the government looking to set a similar example on the implementation of the revised Schedule M and updated GMP standards? Will this stance slowly restore public trust in pharma companies, as well as the DoP which has been accused of being more industry friendly than patient-centric? 2025 could thus be a pivotal year for course corrections for all stakeholders.
VIVEKA ROYCHOWDHURY, Editor
viveka.r@expressindia.com
viveka.roy3@gmail.com