Accept the need that a better working relationship between industry and regulators is crucial for future progress
Day 2 of IPC 2018 saw industry captains and regulatory authorities come together with the aim of building better synergies and strengthen their relationship to serve patients better.
Eminent panelists discussed the various nuances of this relationship in the much-awaited session titled, ‘Can industry and regulators go Hand in hand? To gain the Glory of pharma sector. It’ was moderated by BR Sikri, Chairman LOC-70th IPC; Managing Director ABS Groups of Companies and President, FOPE.
SV Veeramani, Chairman and Managing Director, Fourrts Laboratories emphasized that regulators should be facilitators, educators and coaches to the industry. He opined that regulators need to guide the industry and requested the regulators to take the industry’s views while creating new regulations.
He congratulated DCGI for creating a forum and inviting the industry to share and discuss their problems, suggestions and requirements. He also suggested that regulators should not keep amending the regulations too much and too often as it can adversely affect the growth of the industry and stop the process of innovation.
He stated that the same of the pharma Industry in Gujarat is because regulators and industry understands each other’s problem and cooperate to resolve them effectively.
Dr S Eswara Reddy, Drugs Controller General (India), in his opening remarks, he said that though since the 1940 Drugs and Cosmetic Drugs Act the industry and regulators are working together, we need to further strengthen the relationship. He also pointed out that in comparison to other markets, we have minimal regulation. He also stated that our regulations have helped the pharma industry to grow phenomenally in India and global markets.
He said that regulators’ intention is not to kill the industry but to oversee and standardize the processes. To protect public health, and control discrepancies, both intentionally and unintentionally, we need to have a strong and effective regulatory system.
He said that before sharing any data with DTAB, he shares his industry agenda with the industry manufacturers forum to avoid any conflict of interest. He also raised a point that besides, AIDCOC, all the other industry associations are part of the Industry Manufacturers Forum and urged representation from AIDCOC.
He also mentioned that due to conflicts between industry and regulators, lawyers are getting benefited and both of them to need to put in more efforts to avoid such problems. He also said that better synergy between the industry and regulators would also help to better understand the patients’ perspective.
Dr SM Mudda, Chairman, Regulatory Affairs, Indian Drugs Manufacturing Association, highlighted that there is a need for collaboration between the industry and regulators at the operation level. He briefly mentioned about the common challenges that the industry and the regulators are facing. He recommended that both should make more efforts to understand the global perspective and take adequate measures before it’s too late.
He also stressed on building a cohesive environment where industry interacts with regulators without any hesitation and elaborated on how such an approach can benefit patients.
Dr Rajendra Kumar Sanghavi, Chairman, Medical Committee, Indian Drugs Manufacturing Association talked about the UCPMP code, cross-prescription by non-allopathic practitioners, non-availability of DPCO drugs, BCS class II and IV, clinical trials regulations like video recording, banning of drugs like Pioglitazone based on few response and later ban withdrawal and FDC etc. . He stressed that doctors should be allowed and sponsored to attend conferences, and should be involved in the decision-making processes between industry and regulators as many pharma companies are not really connected with the doctors.
He suggested the CDSCO to have doctors’ representation in their decision-making process. He also highlighted that doctors and NGO interactions with industry and regulators are lacking and they need to be made a part of the process.
NK Ahooja, State Drug Controller, Haryana, emphasized on do’s and don’ts for regulators. He suggested that in a proposal of changing a name of CDSCO we should consider making changes of drugs inspectors to drug controller officer, it will change the perspective and create positive vibes. He also suggested that any new or amended rule needs to be reviewed and discussed with all stakeholders including drug controllers. He also requested the DCGI to consider making drug controllers a part of the ‘Industry Manufacturers Forum’ and proposed that create a definition for New Cosmetics, scrutinize medical device regulations, and revisit the name change of Blood Bank to Blood Centre.
Dr HG Koshia, Commissioner, FDA- Gujarat, briefed the audience on pharma industry’s problems and the furore during the implementation of Schedule – M. He also explained how his department convinced their state-based pharma companies to upgrade and it resulted in benefits for both, the industry as well as regulators. He also mentioned that in Gujarat, both of them are working to harmonize the norms and instead of working hand in hand they are working side by side.
Koshia also mentioned that continuous collaborative efforts need to be executed for the betterment of the society.
The session was well attended by different industry stakeholders and students. Many suggestions were made by speakers for the industry, regulators and patients’ groups.