The Drugs Controller General of India (DCGI) has constituted an Independent Expert Committee on Oncology for examination of reports of serious adverse events (SAEs) of deaths occurred during clinical trials in the country. Dr Arun Agarwal, Professor of ENT, Maulana Azad Medical College, New Delhi is the chairman of the expert committee.
The committee will function under the provisions as specified in Appendix XII of the Schedule Y of the Drugs & Cosmetics Rules.
The chairman of the committee will receive reports of serious adverse events of death from investigators, sponsors or his representatives whosoever had obtained permission from the DCGI for conducting the clinical trial and the ethics committee. The committee will examine the reports of serious adverse events of death, to determine the cause of death and if the cause is due to reasons which are considered as clinical trial related death , then it will give its recommendation to the DCGI.
The committee will examine whether the death has been happened due to adverse effect of investigational products; due to violation of the approved protocol, scientific misconduct or negligence by the sponsor or his representative or the investigator; whether it is due to the failure of investigational product to provide intended therapeutic effect; due to use of placebo in a placebo-controlled trial; due to adverse effects due to concomitant medication excluding standard care, necessitated as part of approved protocol; for injury to a child in-utero because of the participation of parent in clinical trial; and due to any clinical trial procedures involved in the study.
In case of clinical trial related death, the committee will also give recommendation to the DCGI the quantum of compensation to be paid by the sponsor or his representative.
Dr YK Gupta of AIIMS New Delhi; Dr Renuka Kulkarni-Munshi of TN Medical College and BLY Nair Charitable Hospital, Mumbai; Dr Hemant Malhotra of SMS Medical College, Rajasthan; Dr SD Banavali of Tata Memorial Hospital, Mumbai; Dr TN Sagar of Cancer Institute, Adayar, Chennai; Dr Kishore Singh of Maulana Azad Medical College, New Delhi; and Dr S Kataria of Safdarjung Hospital are the other members of the 8-member expert committee.
With a view to provide better understanding of the clinical trial system of the country, Virtue Insight is organising the 5th annual clinical trials summit 2014 that will highlight as a critical guide for successfully conducting clinical trials in India on June 10 & 11 in Mumbai. The event will focus on adapting to India’s transformed regulatory landscapes to conduct clinical trials, re-thinking patient recruitment and patient experience and finding the ideal partner in outsourcing logistics operations in India etc among others.
The event plans to give an overview of Indian healthcare and clinical trial system towards 2015, analysing the recent government rules and guidelines, discovering the new trends in global clinical trials and their role in India. Another highlight will be the technologies that drive efficiencies in global clinical trials, strategies to conduct successful interventional oncology trials in India and get updates on design of clinical drug.
Special focus will also be given on understanding the expectations of regulatory authorities and what type of regulatory structure does India currently have, while deliberating on overcoming challenges faced in regulatory approval processes–obtaining drug, clinical supplies import and export licences in Asia. Experts will also conduct regulatory review at the drugs controller general of India (DCGI) and central drugs standard control organization (CDSCO): science, quality, and speed effectively incorporating GCP and GCPs – Knowing what to-do and what not to do.
Top Industry stalwarts will be coming for the event to share their expertise and knowledge on the same. Some of them are Ketan Lakdawala, vice president, professional services, Medidata (UK); Richard Young, vice president, EMEA, Medidata (UK); Arun Bhatt, president, Clininvent Research; Sofi Joseph, head–regulatory operations, Pfizer; Manish Sharma, AVP and head, medical affairs and imaging, Lambda; Retesh Kumar, associate vice president – global pharmacovigilance, Lambda; Chirag Trivedi, director & head of clinical study unit, Sanofi India; Ravisekhar Kasibhatta, vice president–clinical research, Lupin; Shabbir Rangwala, VP of clinical operations, INC; Rajesh Nachankar, senior manager clinical research, Piramal Enterprises; Bhaswat Chakraborty, senior VP and chair, research & development core committee, Cadila Pharmaceuticals etc. among others.
The Maharashtra Food and Drug Administration (FDA)’s online WHO GMP certificate generation system, introduced by the FDA around two years ago, has now been upgraded through a robust IT backed system to such a level that the FDA is now able to provide the WHO GMP certificate to the exporters in 10 days.
Besides creating an electronic storage of data for easy retrieval at any time, the new online system developed by the FDA ensures avoiding duplication or counterfeiting of the certificates by assigning a software generated unique authorisation code to each certificate. Among the other unique attributes of the system, the SMS delivery system keeps the manufacturers updated when they are offline and authentication of the certificates can be verified by the authorities very easily.
The new system will go a long way in boosting the exports from the state as this new system will help manufacturing units to get WHO GMP certification for exports in 10 days time as compared to three months in the past.
The manual process was time consuming and entailed scrutiny of the application at three levels by the concerned authorities which once approved was sent by post as a Compliance Letter. This system was followed from 2000 to August 14, 2012.
Earlier, joint commissioner (HQ) was designated for signing the various certificates issued under the WHO GMP certificates. Manufacturers from across the state had to come to Mumbai to apply for the certificates and had to submit a sizeable amount of data in the form of papers. The application thus received was cumbersome as it was first received by the drug inspectors at WHO-GMP section and then by the assistant commissioner, WHO- GMP section followed by the final signatures on the certificates by the joint commissioner (HQ).
There are 1703 manufacturing units in the state out of which 247 units are WHO GMP certified. Exports of medicines worth Rs.15,500 crore have been accounted from Maharashtra in the year 2013-14. There are 883 allopathic units, 452 ayurvedic units, 31 homoeopathic units and 337 cosmetic product units across the state.
The Indian government will more than double the number of regulators in three years and set up state-of-the art testing labs at ports to ensure the pharmaceuticals and drugs exports shipments meet global quality standards while following a zero tolerance policy for any laxity, senior officials in the Union health and commerce ministries said.
Speaking on the sidelines of the three-day international exhibition for pharma and healthcare ‘iPHEX’, which began here on May 21, Drugs Controller General of India (DCGI) Dr G N Singh said the central government will be spending over Rs.3,000 crore in the next three years (under the 12th Plan) towards enhancing the capacity of the regulators both at the centre and state levels. While the number of regulators will increase to 1,000 from 500 at the central level, as many as 3,000 regulators will be deployed at the state levels. In India, the regulatory system works at the dual level – at the central and state levels.
Joint secretary in the commerce ministry, Sudhanshu Pandey, said that the Union government is following a “zero tolerance” policy for ensuring that India not only maintains but further strengthens its ranking in the world pharmaceuticals market. He said these measures on quality assurance are even more important when a big opportunity would be unfolding in the off-patent generics in the next few years as more than 160 drugs will go off-patent till 2018. He also made it clear that the government stands behind zero tolerance when it comes to human lives.
India’s regulators including DCGI himself along with state level FDAs have all gathered in Mumbai at the ‘ iPHEX’, organised by the industry body Pharmaceuticals Export Promotion Council of India (Pharmaexcil) and are engaged in deliberations with regulators from 40 countries.
Chairman of the iPHEX organising committee Bhavin Mehta said the ‘iPHEX’ has become a much sought after event among the global buyers who are looking up to India as a dependable source of affordable drugs.
Against the backdrop of several instances of violations to the Drugs and Magic Remedies (Objectionable Advertisement) Act (DMR Act) last year, Maharashtra Food and Drug Administration (FDA) has recently filed First Information Report (FIR) against Mumbai based weight loss firm Dr Bhavana Shah’s Fitness Highway Slimming Beauty and Wellness Pvt Ltd for publishing misleading advertisement in a reputed national daily making a false claim that it is FDA approved.
FDA officials informed that making false claims about the treatment of weight loss by the centre like advance weight loss and that the treatment offered is FDA approved is in violation of certain sections of IPC and Magic Remedies Act. Around 160 notices were served in Thane and 121 in Mumbai last year in violation of the DMR Act. This is the first such case which has come up this year.
“With centres at Borivali, Khar and Andheri, Dr Bhavana Shah’s Fitness Highway Slimming Beauty and Wellness Pvt Ltd had published the advertisement during January this year and stopped publishing it further after a show cause notice was served to them by the FDA. They again repeated the same offence on May 2, 2014 by publishing the same advertisement with the false claim,” said S T Patil, joint commissioner, Konkan Division, FDA.
A team of FDA officials raided the premises of the centre following the misleading advertisement and enquired about the drugs used or the therapy involved but the staff at the centre failed to give a satisfactory answer on their claims. “Therefore, we had to file an FIR against them at Amboli Police Station in Andheri West area of Mumbai. This also amounts to violation of IPC under its non-cooperation clause. The directors of the company were supposed to furnish authentic clinical details about the therapy and other relevant details which they failed to give,” explained an FDA official.
Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, seeks to curtail undesirable advertisements pertaining to drugs and magic remedies because advertising is considered to encourage self medication of harmful drugs. The Act lists the diseases and disorders in respect of which advertising is banned (Under Section 3 and Schedule of the Drugs and Magic Remedies Act, 1954.
The main objective of DMR Act is to control the advertisement of drugs in certain cases and to prohibit the advertisement connected with remedies alleged to posses magic qualities and to provide for matters connected therewith. Under the DMR Act, the definition of “Magic Remedy” includes a talisman, mantra, kavacha and any other charm of any kind which is alleged to possess miraculous powers for or in the diagnosis, cure, mitigation, treatment or prevention of any disease in human beings or animals or for affecting or influencing in any way the structure or any organic function of the body of human beings or animals.