In a step further to digitise its services and usher in transparency in collection and analysis of drug samples, Central Drugs Standard Control Organisation (CDSCO) will soon start online submission of drug samples by drug inspectors for lab testing. The sample analysis report will be put online by the respective CDSCO laboratory.
CDSCO has 7 laboratories including Central Drugs Laboratory (CDL) Kolkata, Central Drugs Testing laboratory(CDTL) Mumbai, Central Drugs Testing Laboratory (CDTL) Chennai, Tamil Nadu, Central Drugs Testing Laboratory (CDTL) Hyderabad, Regional Drugs Testing Laboratory (RDTL) Guwahati, Regional Drugs Testing Laboratory (RDTL) Chandigarh, Central Drug Laboratory, CRI Kasauli.
Online submission of drug samples will be done via Sugam portal, developed by Center for Advanced Computing (CDAC). With an aim to check drug quality, currently CDSCO drug inspectors send drug samples for lab testing along with forms filled by them containing details of drug batch number, manufacturer, manufacturing and expiry date, molecules and formulations etc. They will now be allowed to submit online forms containing details of drug samples collected by them, said a senior CDSCO official.
It will lead to reduction in time required in submitting the hard copy to the respective lab by drug inspectors and fast track the drug testing process. The initiative is a part of slew of measures initiated by CDSCO to make its services online, he said.
In a bid to sensitize drug inspectors about online submission of drug sample forms, CDAC team has started conducting workshop for them for the same. So far drug inspectors involved in drug sample collection in some zones of CDSCO including Mumbai zone have been trained in online submission of forms by the CDAC team.
Once the CDAC team completes training of drug inspectors at all CDSCO zones, the organisation will start online submission of drug sample forms by drug inspectors.
CDSCO has started online application system, Sugam for licensing the import of medical device, drugs, drugs for personal use, drugs for test & analysis and import of cosmetics. With this, users can track the status of application online through an application reference number generated by the system at the time of submitting the application.
In another bid to give momentum to research and clinical trials in the country, the centre eased regulations governing the import and export of human biological samples for commercial purposes. The Directorate General of Foreign Trade issued a notification, August 4, saying that the import and export of such samples “should be permitted by Customs authorities at the port of entry / exit without prior approvals (import licence / export permit) from any other Government agency.”
As long as “the concerned Indian company/agency submits an undertaking that they are following and will follow all the applicable rules, regulations and procedures for safe transfer and disposal of the biological samples being imported/exported as per the related norms/regulations” to the Customs authority at the port of entry or exit, any other approval is no longer required. Prior to this change, such a company or agency had to submit an application to the Indian Council of Medical Research, which then made decisions case-by-case.
In 2011, ICMR had formed a committee of experts, chaired by the director general of the Council, to scrutinise and, only then, clear every sample going in and out of India. Among the documents that had to be submitted to the committee was a copy of the informed consent of the individual patient agreeing to their sample being used for a particular study.
The debate over the ethics of the commercial use of the biological samples has been around for over a decade now. A November 2002 article from the British Medical Journal notes the objection raised by Indian scientists to a genetic study done by British and German scientists on people from coastal Kerala. The article says the concern was that India’s diverse genetic information could be mined for commercial purposes without regulations.
This notification comes on the heels of two circulars issued by the Central Drugs Standard Control Organisation that also made getting approvals for and the logistics of clinical trials and research easier for companies. All three steps have been taken at the same time as the ICMR bringing out its draft National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, which set standards for ethical practices and consent, and safeguard participants.
One circular removed the cap of three trials per investigator. The other says that trial sites no longer need to have at least 50 beds. Both circulars hand over the decision making powers to the ethics committee presiding over each trial. It was also felt that since India has too few principal investigators, restricting them to only three trials at a time was not feasible.
The Central Drugs Standard Control Organisation (CDSCO) may launch online grant of NOCs for conducting clinical trials soon, under SUGAM, an online solution for submission, application and grant of permission, in compliance with Union health ministry’s initiative of e-governance. The application can be submitted and monitored online which will reduce the time of clearance.
In this regard, the CDSCO will also be organising a hands-on workshop on ‘Online process for Grant of NOC for Clinical Trials’ on August 24, 2016 at CDAC Noida and after receiving the feedback, the date of launch will be decided, said an official from CDSCO.
He further said the process and document required are the same and it will reduce the time required in submitting the hard copy to the office. The applicant can submit all the required documents and monitor the status of the application.
The CDSCO in pursuance of implementation of e governance has launched various services for import of drugs, medical devices, drugs for personal use, drugs for test & analysis and import of cosmetics in first and second phases. Now in third phase, the online service for grant of NOCs for conducting clinical trials will be launched.
The organisation has launched an online portal for licensing the import of medical device from March, under SUGAM for the import of drugs. The portal only provided benefit for the grant of registration certificates for import of drugs or import license of drugs and the medical device industry. Now the grant of NOC for conducting clinical trails can also be availed.
Online application system provides an opportunity for user to apply for the grant through online system. It also provides an option to track the status of application online through an application reference number provided by the system at the time of submitting the application.
Central Drugs Standard Control Organisation (CDSCO) and Pharmaco-vigilance Programme of India (PvPI) are jointly framing a set of exhaustive guidelines on par with the existing global guidelines to usher in good pharmacovigilance practices in the country for drug safety.
This comes at a time when the government has mandated the market authorisation holders (MHA) to set up pharmacovigilance (PV) cell in their companies in accordance to the Drugs and Cosmetics Rules, 1945 to collect, process and forward the report to the licensing authority for information on adverse drug reactions (ADRs) emerging from the use of the drug manufactured or marketed by the respective MHA in the country through a gazette notification March 8, 2016.
The guidelines will feature pertinent areas like signal detection for risk-benefit evaluation and risk management programmes. Signal management is not compulsory in the present set of guidelines. Risk benefit of the product can be measured properly through signal detection.
The drug exporting pharmaceutical companies can set up a PV system to fulfill its legal tasks in relation to pharmacovigilance, design to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance.
A pharmaceutical company can meet their pharmacovigilance obligations either by setting up in-house systems for pharmacovigilance or can enter into contractual arrangements with Contract Research Organizations (CROs) specializing in pharmacovigilance function.
Typical activities in PV department are ADR case processing and reporting (electronic or hard copy), Periodic Safety Update Report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER), Periodic Adverse Drug Experience Report (PADER), product quality complaints management, medical inquiries management, safety data exchange agreement management, signal detection for risk-benefit evaluation, risk management programs(RMP), literature monitoring for ADR case reports (including local literature monitoring, EU MLM search), training of company employees on ADR reporting, global compliance monitoring, audits and inspections.
The SOPs are expected to cover all pharmacovigilance functions and should be structured comprehensively detailing the necessary steps. Since pharmacovigilance involves global operations, clearly written SOPs ensures consistency, compliance, and quality, clear assignment of roles and responsibilities, uniform performance over multiple users to avoid errors of oral communication.
The number of SOPs related to pharmacovigilance may vary from few in number to many, depending upon the length and complexity of the processes involved. SOPs ought to reflect the main requirements of the relevant legislation but should also be adapted to the technical and human infrastructure of the company.
List of SOPs for PV Dept involves procedures for collecting the adverse event reports, validating the adverse reaction reports, evaluating the cases for their seriousness, follow up of cases for missing information, expedited reporting, electronic reporting, periodic reports, signal management and risk benefit assessment and response to request for information from regulatory authorities, Interaction between safety issues and product defects, handling of urgent safety restrictions and safety variations, management and use of databases, training, internal audit of the pharmacovigilance system and archiving.
Sources of collection of adverse event reports are health care professionals, consumers, clinical trials, post marketing surveillance studies, regulatory authorities, literature publications, social media, product quality complaints, medical inquiries, pre-clinical research and business partners.
In a decision that will go a long way in boosting the clinical trial industry in the country, the Union health ministry has removed the restriction on the number of clinical trials an investigator can undertake at a time. At present, no investigator should conduct more than three trials at any given period of time. Removing the restriction, the ministry has now empowered the ethics committee to take a final call on the number of clinical trials an investigator can do at any given time after examining the risk and complexity involved in the trials.
Earlier, there were objections from the stakeholders including the clinical trial organisations in the country against the health ministry’s decision to restrict the number of clinical trials an investigator can do at a time as they felt that the restriction was impeding clinical research in the country as this has led to the under-utilisation of the healthcare infrastructure developed over the last one decade on one hand coupled with high attrition rates in the industry.
Experts were of the opinion that studies conducted for vaccines may require 10,000 trial subjects whereas studies on cancer may require 60 to 70 trial subjects. Therefore, restricting the number of studies for an investigator is not justified in the interest of clinical research. Institutional ethics committee should be given the power to govern the number of studies an investigator can undertake based on requirement of a particular study because in each therapeutic area the study requirement varies immensely.
In the light of widespread resentment against the restriction, the Union health ministry convened several meetings with the industry associations and other stakeholders. To deliberate stakeholders concerns and the way forward relating to some issues on conduct of clinical trials in India, two such meetings were held on 20.8.2015 and 6.10.2015 under the chairmanship of secretary, ministry of health in which other experts in the field were also present.
After detailed discussions and deliberations, the ministry decided to do away with the restriction. “As regards restriction that no investigator shall conduct more than three trials at any given period of time, it has been decided to remove this restriction and it is further decided that ethics committee after examining the risk and complexity involved in the trial being conducted/proposed shall decide about how many trials an investigator can undertake”, Drugs Controller General of India (DCGI) Dr GN Singh, in his order said.