Central Drugs Standard Control Organisation (CDSCO) recently issued a series of notices on clinical trials and drug safety announcing the actions to be taken by the Ministry of Health and Family Welfare. The MoH&FW has finalised these orders after deliberating on the recommendations proposed by an expert committee it had put together, under the chairmanship of Prof Ranjit Roy Chaudhury, to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs.
The 14 orders, dated July 3, cover much-debated issues like compensation for trial-related injury/death, design of placebo controlled trials, etc and are still being studied by industry to gauge their impact. Below is a summary of each order.
Renaming of committees
According to one of the orders, New Drug Advisory Committees (NDACs) will be renamed as Subject Expert Committees. The members of their meetings will be drawn randomly from large pool of experts. Applications of clinical trials and new drugs will initially be evaluated by the Subject Expert Committees and their recommendations will be reviewed by Technical Review Committee (TRC). CDSCO will grant approval of clinical trial and new drugs based on the recommendations of TRC.
Grounds for banning of marketed drug
It has also been decided that if two or more countries take a drug off their market on grounds of efficacy and safety, then the continued marketing of the drug in India will be considered for examination and appropriate action.
Cell created for coordination with institutes like ICMR
The report of the expert committee had pointed out that the CDSCO may need information continuously on post-marketing surveillance of drugs, rational use of medicines, drug utilisation studies and adverse drug reaction monitoring and thus recommended the creation of cell for coordination with institutes like ICMR for sponsoring various studies. The MoH&FW has ordered the creation of such a research unit within CDSCO. A three-member cell, within CDSCO, currently constituting Dr A Ramkrishan, Deputy Drugs Controller India; Somnath Basu, Assistant Drugs Controller India and M Balakumar, Drugs Inspector, all based at the CDSCO headquarters, will coordinate with agencies like ICMR for the conduct of such studies,
Undertaking to file for marketing approval
If India participates in global clinical trials of NCE(s) to be used for diseases prevalent in India, after marketing approval is received in the innovator country or in well-regulated developed country markets, CDSCO’s approval should be sought for marketing these NCE(s) in India. After approval from CDSCO, the order specifies that ‘these NCEs should be marketed in India speedily, preferably by production within the country’. The order directs all sponsors / clinical trial applicants to provide an undertaking to this effect.
Design of placebo controlled trials
The MoH&FW order requires pharmaceutical companies, investigators, drug regulators and the ECs to ensure that the design used in a placebo-controlled clinical trial is appropriate, efficient and ethical and directs NDAC members that only such placebo-controlled trials are considered for approval. This is based on the report’s observation that placebo controlled trials are fairly uncommon these days, although there will always be a case for them in special circumstances. Since other remedies are usually available, there is no reason to deprive a patient of a drug in such placebo controlled trials.
Requirements for trials of generics, biosimilars in India
On the subject of requirements of local trials of generics or biosimilars, the decision has bee taken that drugs considered generics and similar biologics (biosimilars) in other countries like the US that have been marketed in such countries for more than four years and have a satisfactory report would be approved for marketing in India after abbreviated trials. NDAC experts have been requested to evaluate the such applications with these requirements in mind.
Criteria for deciding ethnicity of new drugs
With regard to the considerations of ethnicity for approval of new drugs, the MoH&FW order specifies 10 properties of a compound, which make it more likely to be sensitive to ethnic factors, which shall be taken into consideration during evaluation of new drug applications. the same order also specifies another eight factors to considered while deciding whether the available data could be ethnically sensitive or insensitive.
Waiver of clinical trial
The Ministry has ruled that waiver of clinical trial in Indian population for approval of new drugs, which have already been approved outside India, can presently be considered only in cases of national emergency, extreme urgency, and epidemic and for orphan drugs for rare diseases and drugs indicated for conditions/diseases for which there is no therapy.
Approval of academic clinical trials
Academic clinical research may be approved by the Institutional Ethics Committee (IEC). However, if a new drug is being evaluated or a new use for an existing drug is being evaluated, then approval of the DCGI is needed as per Drug & Cosmetic Rules.
Compensation for injury or death
According to the order, the MoH&FW has decided that compensation in case of injury or death discerned at a later stage should be paid to the trial participant Or his/her nominee as the case may be, if any drug-related anomaly is discerned at a later stage and accepted to be drug related. The order therefore advices all sponsors/ manufacturers/ clinical trial applicants to provide compensation accordingly.
Clinical trials of medical devices
The order recognises that clinical trial of a medical device is different compared to that of drugs or vaccine, as there is no concept of conducting Phase 1 clinical trial to assess safety, tolerability of the medical device. However, the MoH&FW has decided that the procedures for clinical trials approval, accreditations of investigators, sites, Ethics Committee and such other conditions would be similar to the clinical trials of new drugs/vaccines.
Providing ancillary care
The MoH&FW has decided that there should be provision for providing ancillary care to patients suffering from any other illness during the trial. Thus all sponsors/ manufacturers/clinical trial applicants have been advised that such ancillary care should be provided to the clinical trial subject for brief illness in the same hospital/ trial site, wherever required.
Three trial-limit for investigators
The order states that the number of clinical trials an investigator can undertake should be commensurate with the nature of the trial, facility available with the investigator, etc. However, under no circumstances the number of trials should be more than three at a time. All sponsors/ clinical trial applicants have been directed to ensure that the above recommendations are implemented and the investigators are not involved in conduct of more than three clinical trails at a time.
Number of phase III trial subjects
If Indians have participated in Phase III global clinical trials, the number of participants need to be adequate for considering approval of the drug in India and the order directs NDAC to evaluate applications while adhering to this requirement.
EP News Bureau – Mumbai
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