Industry wants health ministry to come out with rejoinder clarification to protect image of Indian generic industry
Concerned over the disturbing media reports published recently, questioning the quality of Indian generic drugs exported worldwide, Indian drug manufacturers across the country have demanded to the Indian government to immediately issue a rejoinder clarification on this matter, clearing the air. The industry fears that failing to take any requisite action, in time, may impact the reputation of the Indian pharma industry as majority of the companies thrive on exports.
Industry insiders pointed out that it has become a hackneyed pattern for the media to keep on attacking the authenticity and reliability of the Indian generic industry, without having any proof of the same, acting on the vested interest of the foreign MNC lobbies. Making matters worse is the lacklustre attitude of the Indian government, which seldom takes up any responsibility to demand clarification on such maligning reports which further thwarts the interests of the industry.
A reliable source from the industry stressed that, it is high time for the health ministry to come out with a rejoinder clarification, elucidating its stand on the issue of quality parameters adopted in the country, to protect the image of Indian generic industry. Many in the industry feels that only a stern intervention from the government will ensure that no one gets a free reign to play with the interest of the Indian pharma industry.
“Ironically such reports are not only a threat to the Indian pharma industry alone, but also an insult to the Indian drug regulators as well. Indian drug regulatory system is one of the strongest in the world and Indian drug manufacturers make sure that we follow all the drug regulations properly. That is why today we are one of the top exporters in the world, then why suddenly should we go on spree to harm the reputation of our industry which we took years to build on,” questioned a disgruntled industry expert.
Dr H G Koshia, commissioner, Food & Drugs Control Administration (FDCA) pointed out that as a regulator he is also concerned by such reports as it may impact the business interest of the Indian manufacturers and the reputation of the Indian regulators, globally. He added, “When such incidence happens in the state of Gujarat, we make it a point to demand clarification from the concerned department on this issue, to ensure that no one is indicted wrongly. Considering that Gujarat is one of the major exporters of pharma products in the country, it is a matter of huge concern for us as well and all steps will be taken by us to ensure that the issues of our manufacturers are well represented at the centre.”
Resolve Therapeutics, LLC, a privately held biotechnology company based in Seattle that is dedicated to helping patients with lupus through the development of its platform of targeted nuclease therapeutics, has initiated clinical studies with its lead compound RSLV-132.
Resolve administered the first doses to humans of RSLV-132 its first-in-class targeted nuclease therapy designed to decrease the burden of circulating RNA-containing immune complexes in SLE patients. Ongoing studies are designed to evaluate the safety, tolerability, pharmacokinetics and biological activity of RSLV-132. A single escalating dose study in healthy volunteers began earlier this month, with a multi-dose study in SLE patients planned to begin in the second quarter of 2014.
RSLV-132 is a novel Fc fusion protein consisting of human RNase attached to the Fc portion of human IgG. The goal of the therapy is to reduce the burden of circulating RNA-containing immune complexes which are thought to be the most proximal trigger of the systemic inflammation characteristic of SLE. By eliminating the RNA cargo contained in circulating immune complexes the therapy is designed to prevent chronic activation of nucleic acid sensing toll like receptors (e.g TLR7 and TLR8) and subsequent activation of the interferon inflammatory cascade. Additional therapeutic benefit is thought to result from dampening B-cell activation, as well as mitigation of the direct tissue damage caused by immune complex deposition in key organs, such as the kidney and brain.
“We are thrilled to begin the clinical testing of RSLV-132, bringing this potentially important new approach for treating lupus one step closer to the large number of SL patients that are not well controlled with current therapy” commented James Posada, chief executive officer of Resolve Therapeutics.
Even as criticism is levelled that the meetings of New Drug Advisory Committees (NDACs) many times did not have the presence of all the experts, the government is planning to raise the number of the NDACs from 12 at present to 50 on a gradual basis.
The Central Drugs Standard Control Organisation (CDSCO), pushed by the Parliamentary committee on the functioning of the regulatory mechanism and under pressure from the judiciary, had formed 12 NDACs to advise on matters related to review and regulatory approval of clinical trials and new drugs (except for Investigational New Drugs).
The new proposal, as suggested by the technical committee and approved by the apex committee on clinical trials, is to increase the number of NDACs to 50 with a view to involve more experts in the process of clearing the clinical trials in a fool-proof manner. Sources said the process for getting approval for forming more NDACs had already been initiated.
The CDSCO is also planning to expand the panel of pharmacologists as in many cases, the absence of pharmacologist had hampered the decision-making process of the expert committees. It is learnt that several applications for clinical trials approvals were held up as pharmacologists, who are part of the NDACs, were not present during deliberations.
The Apex Committee on clinical trials headed by the Health Secretary has also reportedly taken note of the situation. It was pointed out that NDACs even made recommendations even without proper representation of specialists including pharmacologists in several cases in the past.
In some of the NDACs, the expert members have retired, some of the members are no more associated with the organisation and some had refused to attend the meetings, citing busy schedules and engagements, thus defeating the very purpose of the NDACs. The practice is that the pharmacologists specified for particular NDACs are only called to offer expert opinion, not full-time attendance at the meetings.
The apex committee has already directed that whenever a pharmacologist in the panel is absent, the minutes of the NDACs along with the presentation of the firms and supporting literature should be referred to the pharmacologist approved in the panel of NDAC for his opinion.
Apex committee on clinical trials to have greater say in waiving off requirement for local trials for foreign drugs
The Apex Committee, set up by the Union health ministry to regulate and supervise the clinical trials, is going to be the final authority to extend waiver of local clinical trial requirement for approval of new drugs which have been approved in other countries.
The waiver would be granted only under certain criteria like national emergency, extreme urgency, epidemic and for orphan drugs for rare diseases and drugs indicated for conditions and diseases for which there is no therapy and will be vetted by the apex panel, according to the health ministry.
Sources said in case local clinical trial waiver is required for any other category, the matter should be brought before the committee for consideration along with the recommendations of the technical committee, another panel set up by the Ministry in accordance with the directions of the Supreme Court on clinical trials sector.
The move is in line with the recommendations by the Parliamentary panel and the expert committee headed by Ranjit Roy Chaudhury on clinical trials. The ministry had already taken the decision to allow waiver of local trials only under the above said conditions like national emergency, extreme urgency, epidemic and orphan drugs for rare diseases.
The matter was first discussed by the technical committee and then came to the apex committee, headed by the Secretary of the health ministry. The panel accepted the recommendations by the technical committee to further streamline the process for granting waiver of local trials.
According to the existing rules, for new drugs approved in other countries without local clinical trials in the country, phase III trials are required before granting the permission to manufacture and import of finished formulation of the new drug.
But, requirements of local clinical trials may be waived off or relaxed under certain conditions as per Drugs and Cosmetics Rules 122 A (2), 122 B (3) and clause of 1 (3) of Schedule Y. The licencing authority may in public interest decide to grant such permissions on the basis of data available from their countries. Further, the submission of requirements relating to animal toxicology data may also be modified or relaxed under same rules in case of new drugs approved and marketed for several years in other countries and adequate published evidence regarding safety of the drug is available.
The Parliamentary Standing Committee on Health in its 59th report had raised the issue and concerns about the manner in which the local trial requirement was waived off and the matter was also dragged to the Supreme Court. The Government, following this, set up the expert panel under Prof Chaudhury and decided to tighten the rules.
ICMR issues draft guidance document on ‘Research for biological (biomedical) prevention of HIV infection’
To promote research on biological/biomedical options including vaccines, microbicides, treatment for prevention and other strategies for preventing HIV infection, the Indian Council of Medical Research (ICMR) has issued a draft guidance document on ‘Research for biological (biomedical) prevention of HIV infection’.
The draft document is meant to provide guidance for researchers in the field and also to position this document as an advocacy tool for greater support for biological/biomedical prevention options. The guidance document addresses the current status of research and research needs with reference to the different facets of prevention research including preclinical development, clinical trials and access; the gaps that need to be addressed and infrastructure needs.
According to senior officials in the ICMR, the guidance document has been prepared after extensive consultation with experts in this field. The ICMR has invited comments and suggestions from experts and other on this draft guidelines for finalization of the document till April 30, 2014.
Officials said that recent breakthroughs in HIV biomedical prevention research open new doors to reducing the scope of the epidemic. This progress also poses new questions and brings new challenges as we continue to move HIV biomedical prevention research forward. Understanding the needs and gaps in these efforts will help in providing appropriate direction and further impetus for research on biomedical prevention tools.
Currently, the country has an estimated more than 20 lakh people living with HIV/AIDS in 2011. The Indian epidemic is geographically diverse and is a mix of generalized and concentrated epidemics in different districts.
Overall high disease burden due to HIV, continuing high prevalence of HIV infection in certain populations and geographic areas and the limitations associated with interventions for behaviour change underline the need for a basket of biomedical options for prevention of HIV infection in India.
Along with necessary individual, social, structural, societal and developmental changes, a broad range of biomedical HIV prevention and treatment options is required to meet the diverse needs of individuals and populations. Comprehensive HIV prevention requires a combination of programmatic and policy actions that promote safer behaviours; reduce vulnerability to transmission; encourage use of key prevention technologies; promote social norms that favour risk reduction; and address drivers of the epidemic.