India: Health Ministry Panel To Frame Clinical Trial Policy

Last Updated: 27 February 2013
Article by PSA and Ashutosh Chandola

The health ministry has set up a seven-member expert committee ("Committee") to formulate policy framework for the approval of new drugs and clinical trials. The Committee would study the feasibility of conducting clinical trials in local population for drugs which have already been approved in other regulated markets such as the US, Japan and Europe and would also recommend guidelines for post marketing trials to ascertain the impact of drugs which have been already launched in the market. Another of its role will be to lay down the requirements of global clinical trials, for a new drug discovered abroad which seeks approval here. It will also cite the functions of ethics committee attached to a clinical trials and prescribe the way to monitor them.

PSA view  – Though a welcome move, the success of formulating such a Committee can only commented upon once the policy is released and successfully implemented. It has been seen in many case, be it with regard to compensation for the injured party or the family of the dead in a clinical trial or amendments to the pricing guidelines, that policies are made, even comments from the public are sought; however, the implementation of these policies takes a lot of time which in turn somewhat thwarts their effectiveness.

CDSCO to pre-screen SAE

A recent amendment to the Drugs & Cosmetics (D&C) Rules introduced rule 122DAB which empowers the DCGI to determine the quantum of compensation that is to be paid to the family of the subject in case of a SAE in clinical trial. This amendment was introduced to allow a case by case review of the facts and circumstances that lead up to the SAE and accordingly determine the extent of negligence by each of the parties involved. Further to this, the CDSCO has now introduced a system to prescreen all SAE Reports that are to be considered by the DGCI. The prescreening will be done by CDSCO officers based on a prescribed checklist for determining the acceptability of an SAE report in order to ensure that it contains all necessary administrative and technical information necessary for ascertaining the nature and cause of the SAE, thereby allowing prudent determination of the quantum of compensation.

PSA view  –  The purpose for introducing the prescreening process appears to be to streamline the process for screening of all SAE reports and to make the process more efficacious. While the intention is praiseworthy, adding another administrative layer to the process of determining the quantum of compensation may not work out to be in the best interest of the subject and the families. While it is essential to ensure that all administrative and technical information is provided in the SAE reports prepared for the DCGI, it may be more efficacious if including this information is made mandatory for the parties preparing the reports, instead of having an additional agency check them for inconsistencies.

States express reservations about Food Security Bill

A majority of the State Governments in India have expressed their reservation about passing the Food Security Bill in the budget session. The said bill is an attempt by the Central Government DFPD to ensure that people specified below a particular economic strata have access to a minimum amount of food grains and necessary food items. However, many States have opposed many provisions in the aforesaid bill as there are many contentious provisions. The states categorically opposed cash transfers in lieu of grains as they are utterly confused about how to identify the beneficiaries. The states also argued that there is a lack of availability of grains to match it with the detailed distribution schemes provided in the bill. Many states have also suggested that the Central Government should include more food items like pulses and edible oils so and to take into account the already existent public distribution schemes regarding food grains that are in operation in various states.

PSA view  –  The purpose hurrying with the present bill appears more political than practical. If the Central Government is really serious about proper implementation of the Food Security Bill, it should genuinely look to arrive at a consensus with the concerns of the various State Governments. The proper implementation of the provisions of the bill will ensure an effective public distribution system rather than being an impediment and failure like other Central Government schemes.   

FSSAI extends registration deadline for FBOs

Under the Food Act and its Food Safety and Standards (Licensing and Registration of Food Business) Regulations, 2011 it has been made necessary for the existing FBOs carrying on food business in the country to get themselves compulsorily registered with the FSSAI. The FSSAI had to yet again extend the deadline for registration for the existing FBOs by a year from February 2013 to February 2014. This is the second time the deadline has been extended. The Confederation of All India Traders ("CAIT") has been alleging that the food regulations are formulated keeping the interests of foreign investors and not the domestic existing FBOs.

PSA view  –  Though the requirement of registration is essential to maintain and affirm the safety and standard of food in India, it is becoming largely impossible unless all the FBOs are registered with FSSAI. The FSSAI cannot monitor all unregistered FBOs and with the extended deadline it has provided the respite to unregistered FBOs as the CAIT has been opposing this move.     

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