Conference on New Drugs and Clinical Trials Rules Organized by IPA (Delhi Branch)

New Delhi, July 13, 2019: A one day national conference on “Challenges and Prospects for Clinical Trials (CTs) in India-From Regulator’s Viewpoint” was organized by the Indian Pharmaceutical Association-Delhi State Branch (IPADB) on June 15, 2019 at Eros Hotel, Nehru Place, New Delhi. The key focus areas of the conference were as follows: new rules & regulations for CTs 2019; CTs for AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy) & herbal medicines; CTs for new Investigational Medical Devices (IMDs); and CTs for cosmetics & nutraceuticals.

The conference started with the welcome address by Dr Naresh Sharma, President of IPADB & Deputy Drugs Controller-India (DDCI), Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare, Government of India who gave a brief introduction about the conference. The function was inaugurated by the chief guest, Dr V.G. Somani, Joint Drugs Controller (India), CDSCO, who, in his inaugural address, gave an overview on ‘Salient features of new drugs and CT rules, 2019.’ The key highlights of the new rules, he said, were timelines defined for CT of new drugs; increased application fees; compensation for injury or death as per defined formula; academic trial where Drugs Controller General of India (DCGI) permission is not required; Bio-Availability (BA) or Bio-Equivalence (BE) centre needs to be registered; Post Trial Access (PTA) needs to be provided; and provision for CT waiver if drug is approved & used in recognized countries for two years, with condition to do Phase-IV, accelerated approval are made in rare disease based on Phase-II data, and expedited review process (in rare or life threatening disease before completion of Phase-III trial). He also briefed about 13 chapters, 8 schedules, and various CT forms under eighth schedule. Dr Somani concluded, “There are certain logistical issues, viz. IT & bandwidth, and we are still working on pdf format. But we assure our stakeholders that as far as legal clarity, rationality and harmonization with the world are concerned, the new rules have achieved their objective to get the best out of the clinical process while keeping the patient interest in mind.”

The keynote address on ‘Introduction to CT rules & ethical consideration’ was given through a recorded video speech by Prof (Dr) Y.K. Gupta, President, All India Institute of Medical Sciences (AIIMS)-Bhopal, Madhya Pradesh. Giving brief highlights of the new rules, he informed, “One of the major changes in new CT rules is that Schedule Y has been replaced by new CT rules 2019 for humans but Schedule Y is still valid for veterinary drugs and medical devices. There is more clarity on the definition of new drug, IMD, New Chemical Entity (NCE) and biomedical research. Also three types of ECs have been defined, viz. institutional EC which is constituted by head of institution, independent EC where experts get together and EC for biomedical research. EC needs to be registered with DCGI and has been empowered to give approval of any regulatory trial & non-regulatory trial as well.” He added, “It’s the first time that orphan drugs have been well-defined in the new rules and the fees for CTs of such orphan or rare drugs have been waived-off. Also, PTA issue has been addressed and EC registration is required only once in 5 years. Earlier, point of contention was that each EC has to get accreditation by Quality Council of India (QCI), which was mandatory. Now, the present rule provides no such mandate for such accreditation to be taken. This has been made optional and implies that the responsibility of institutional EC is now even greater.” Also, in the new rules, Dr Gupta elaborated, “The EC members should be well-trained otherwise they cease to be the members of EC. This has posed as a huge challenge for all EC members. Other important changes were approved timelines and provision of pre- submission as well as post-submission meetings. These changes are primarily to promote ethical CR in India, to bring more transparency & time predictability in the system and to harmonize as per ICH guidelines. This will result in CT to be more patient- centric, science-centric and also bring clarity among the various stakeholders.”

Prof Roop K. Khar, Immediate Past President of IPADB & Principal of B.S. Anangpuria Institute of Pharmacy (BSAIP), Faridabad, Haryana, in his address, summed, “The Indian Government has done the right thing in coming up very clearly with the new CT rules and guidelines. In particular, Schedule Y has been given a new shape and submerged with the new CT rules 2019 and is now applicable for veterinary drugs only.” Some of the dignitaries who graced the inaugural function were: Dr Chirag Trivedi, President, Indian Society for Clinical Research (ISCR); Dr Harvinder Popli, Dean & Officiating Registrar, Delhi Pharmaceutical Sciences & Research University (DPSRU), New Delhi; Dr Gaurav K. Jain, Senior Assistant Professor-Department of Pharmaceutics, School of Pharmaceutical Education & Research (SPER), Jamia Hamdard, New Delhi; Kalhan Bazaz, Vice-President of IPADB & Editor of The Indian Pharmacist; Dr Neeraj Kumar, Joint Secretary, IPADB; Rajesh Agarwal, Executive Council (EC) Member, IPADB; and  Sameer Ahuja, EC Member, IPADB.

After the inaugural function, the seminar was divided into five technical sessions.

Dr V.G. Somani chaired and Dr Chirag Trivedi co-chaired the first session on “New Rules and Regulations for CTs” where Dr K. Bangarurajan, Joint Drugs Controller (India), CDSCO spoke on ‘Process and methodologies for approval of CTs in India.’ The second speaker, Dr Naresh Sharma spoke on ‘Process and methodologies for approval of global CTs.’ In his lecture, he discussed importance of Clinical Research (CR) in India and gave an overview of approval process of global CTs of India, Japan, Europe and the US. He informed, “India has 17% of the global population, 20% of the global disease burden and only 1.2% of the global CTs ongoing at present.” In fact, he stated that more CR was needed to develop new and effective medicines & vaccines to tackle India’s mammoth disease burden and unmet medical needs. He also discussed unseen areas of CT approval process such as degradation products, isomeric / polymorphic forms, change of excipients, change of Active Pharmaceutical Ingredient (API) synthesis process, compatibility of formulation, variations of specifications, effect of ageing API, effect of ageing Primary Packaging Material (PPM), and manufacturing variations. Dr Manoj Karwa, Head-BA/BE, Auriga Research Pvt. Ltd., the third speaker of the session, spoke on ‘Process and methodologies for approval of BA and BE studies.’ In his lecture, he gave an outline of BA / BE studies with respect to its application, import of new drug, manufacturing new drug, EC, Serious Adverse Event (SAE) reporting and compensation.

In the second session on “New Rules and Regulations for CTs”, chaired by Dr K. Bangarurajan and co-chaired by Dr Naresh Sharma, three speakers spoke on the occasion. Dr Renu Razdan, Senior Vice President, J.S.S. Medical Research India Pvt. Ltd. highlighted ‘Government fees & compensation to be paid in case of CT related injury or death as per new Drugs & CTs Rules, 2019.’ In her presentation, she discussed when to pay financial compensation; how to calculate financial compensation; factors to be considered for financial compensation; and responsibility of the stakeholders, viz. investigator, sponsor, EC, independent expert committee & central licensing authority, in such scenarios. On the other hand, Dr Arun Sundriyal, Director-Clinical Management, PPD Pharmaceutical Development India Pvt. Ltd., spoke on ‘SAE and Pharmaco-Vigilance (PV).’ He discussed impact of changes in the new CT rules & regulations; key differences between CT & medical device regulation; and the responsibilities of investigator, sponsor & EC. In the end, he suggested the following: online SAE submission or software with audit trail and tracking for site & applicant; regular interaction with key stakeholder to discuss ongoing issues; single PV department & platform for trials (drug, device, AYUSH & marketed product); harmonization of CT related regulation in different fields like new drug, medical device & AYUSH; and guidance document to address gap, issues or grey areas. The third speaker of the session was Dr Khalid Khan, CEO, Fermish Clinical Technologies, who spoke on ‘Eighth schedule of new drugs & CT rules 2019.’ He also discussed the limitations of Schedule Y and how the gaps were filled in the new CT rules. He also briefed the audience about various forms in the eighth schedule ranging from CT-01 to CT-27 and their applicable fees.

Dr Ravi Kant Sharma & Gaurav Verma, Director-Regulatory Affairs (RA), Becton Dickinson, chaired and Vivek Malhotra, Manager- RA/QA/GA, Stryker India Pvt. Ltd. co-chaired the third session on “CT for New IMDs.” The three speakers for the session were as follows: Dr Ravi Kant Sharma, DDCI, CDSCO spoke on ‘Regulation of IMDs in India’; Ms Mamta Makkar, Senior Manager-RA, Edwards Lifesciences (Approval process for CT of IMDs); and Ms Gunjan Verma, Director, Asia Actual LLC highlighted ‘Challenges in clinical investigations of IMDs as per MDR 2017.’

The fourth session, chaired by Prof Roop K. Khar and co-chaired by Dr Farhan Jalees Ahmad, Professor-Department of Pharmaceutics, SPER, Jamia Hamdard, discussed “CT on AYUSH & Herbal Medicine”. The first speaker of the session, Dr Vikas Punetha, Manager-RA, Amway Research & Development (R&D) spoke on ‘Ayurveda & clinical study’. In his lecture, he highlighted various herbal product categories, laws regulating herbal product in India and why CTs are needed for ayurvedic medicines. On the other hand, Dr Himanshu Tiwari, Head-R&D, Multani Pharmaceuticals spoke on ‘Current practices of CT in AYUSH and herbal medicines’. Dr Sasibhushan Vedula, Senior Manager-Healthcare, Dabur Research & Development Centre (DRDC), Dabur India Ltd., the third speaker of the session, spoke on ‘Challenges in conducting CT (study) for AYUSH and herbal medicines.’ He said, “The challenges in clinical studies on ayurvedic & herbal products are identification of investigators or sites; few CR organizations have knowledge of both science & Ayurveda; consistent quality of formulations; dose, regimen & duration; concept of flexi-dose therapy; complex study design; involvement of biostatisticians; Good Clinical Practice (GCP) compliance; and not fully regulated.” Dr Vedula further commented, “Herbal drug development and CR should take care of the best possible design, methodologies, using modern  tools but taking care of Ayurveda principles in mind, and above all, give top priority to the patients.”

Dr Khalid Khan as chairman and Dr Gaurav K. Jain as co-chairman for the fifth session on “CT on Cosmetics & Nutraceuticals” where the speaker, Dr Saurabh Arora, Executive Director, Arbro Pharmaceuticals Pvt. Ltd. discussed ‘Current scenario of CT in nutraceuticals.’ He gave Indian regulatory definition of nutraceuticals, why are CTs needed for nutraceuticals, challenges in nutraceutical trials and current process for CTs of nutraceuticals.

After each session, interactive panel discussions between the speakers and the participants were also held where speakers cleared the doubts among the delegates on new CT rules issued by CDSCO. Also, certificate of participation were issued to the delegates and the resource persons at the end of the workshop. Finally the conference ended with concluding remarks by Dr V.G. Somani and vote of thanks proposed by Dr Naresh Sharma.

Corporate Comm India (CCI Newswire)