Drug and Clinical Trial Policies

The drug policy of a nation is an important tool to provide guidelines to the pharmaceutical industries and thereby control and regulate pharmaceutical products. As such drug policy in India has been framed and rules were formulated under Drugs and Cosmetics Act, 1945.

The policy is aimed to: provide essential pharmaceutical products at reasonable prices, facilitate and strengthen the indigenous produce at cost effective prices without any compromise with the quality, facilitate export of pharmaceuticals by reducing trade barriers and promote research and development in pharmaceutical sector.

The drug regulatory system in India exists at central and state level with later recapitulating the rules of the central regulatory system. Central drug regulatory authority is Central Drugs Standard Control Organization (CDSCO) that comes under the Directorate General of Health Services of the Ministry of Health & Family Welfare.

It is headed by Drug Controller General of India (DCGI). CDSCO discharges the functions assigned to the central government under the Drugs & Cosmetics Act. CDSCO is authorised to perform: Frames policies and procedures for implementation of the Act; Assists in setting and implementation of standards for Drugs, Cosmetics and Medical Devices through it; Exercises regulatory control over the import of medicines, approval of new medicines and clinical trials, and act as Central Licence Approving Authority (CLAA); Coordinates and liaises with the international bodies like WHO, FDA, EMA, etc; Exercises quality control of imported medicines through the port offices; Maintains drugs testing laboratories for testing of samples; Carries out joint inspections through the Zonal Offices and coordinate actions with the state Drug Controllers under their jurisdiction.

At state level, Food and Drug Administration (FDA) are the authorities that regulate manufacture, sale and distribution of drugs, and in addition also control quality of food articles. In union territories (administered by union Government), FDA authorities provide licences to drugs manufacturing sites and establishments for sale or distribution of drugs; approves drug testing laboratories; monitors quality of drugs and cosmetics; investigates and prosecute in case of contravention of legal provision and if required, recall substandard drugs.

Various amendments in Drugs & Cosmetics Act, 1945 have been made from time to time. All these amendments are being made to regulate the import, manufacture, distribution and sale of drugs in India based upon the need felt. In 1985, The Narcotic Drugs and Psychotropic Substances Act was passed to control illicit trafficking of the narcotic and pyschotropic substances.

In J&K drug de-addiction policy was recently adopted in Jan, 2019 to control menace of drug addiction. Centrally the Act has been amended by several times and more recently in 2014 considering the need of these substances in pain management especially of cancer patients. In 1995, an order [The Drugs (Prices Control) Order (DPCO)] was passed to control the prices of the drugs.

Later it was amended in 2013 and 2015 to include medicine (along with dosages and strengths) under the National List of Essential Medicines (NLEM). Under the DPCO, National Pharmaceutical Pricing Authority (NPPA) has been created to check the drug prices in India.

India despite harbouring the 2nd largest population in the world with highest disease burden has less than 1.2% of the global clinical trials. To give impetus to the research, Union Health Ministry, GoI modified the Drugs and Cosmetics act, 1945 to lay down rules for new drugs, their bioavailability / bioequivalence, clinical trials, and ethics committees.

The New rules have come to promote the research at local level and ease the regulations for newer drugs. However, amendments made are seen by civil society as pharma friendly at the cost of clinical trial participant’s safety. Below are some of the amended points highlighted:

•             Ease of experimental study

      To include a drug into clinical trial, prior basis of experimental animal study is must. To boost local research, rules have been framed to provide waiver for experimental study of new drugs already studied, approved and marketed for more than two years, outside India provided Central Licensing Authority is satisfied.

•             Appeal for sponsors but not for participants

                The clinical trial ethics committee members and/ or sponsors have an option to appeal for reconsideration of the DCGI decision but the option has been subjugated for clinical trial participants. Previously, researchers would provide free medical management “till such time it is established that the injury is not related to the clinical trial”. In a recent modification to the rules, a dubious phrase “as per the opinion of the investigator”. In contrast, no window has been kept through which the clinical trial participant could appeal. In addition, the no-fault compensation that was previously being considered has been removed. Thus, the trial participants/ legal heirs do not have option to appeal for no-fault compensation in case of trial related injury or death.

•             Hastened process but less effective

                Another aim in this amendment is to have predictable, transparent and effective regulations for clinical trials, although no definite mode has been offered to present transparency of the clinical trials to the participants or other researchers. Generally, it takes a lot of time to get approval for the clinical trial and as such decision of DCGI on approval of the trial has been reduced from 180 days to 90 days for drugs developed outside India and to 30 days for trials in India. In case permission for Indian trials is not provided within the stipulated time, it may deem to have been granted. This may facilitate and encourage clinical trial industry but such hastening process of approvals may sacrifice safety. Besides, authorities may deliberately wash their hands from the responsibilities of clinical trial approvals.

•             Trial waiver for drugs researched outside

                It is better to provide more recent and advanced medicines available to the Indian population. As per the recent amendment, the new drugs developed outside India with no serious adverse effects and being approved and marketed in countries (European Union, UK, Australia, Japan and US) may be waived for local clinical trial and approved for use. This order may however, lead to concealment of the drug adverse effects from the sponsors and may also put stakeholders to the risk as the ethnic variation too determines drug effects (for which Phase III clinical trial is conducted). This type of step is criticised by the local drug makers, however, it may be justifiable for the orphan drugs for which pharmaceutical industry has little interest.  

•             No price regulation for patented or newer drugs

                Apart from amendments in the trial participant safety, amendments have made in Drugs Price Control Order (DPCO). Under the amendment new drugs, patented under the Indian Patent Act, 1970 (39 of 1970), have been waived from price regulation for five years from the date of commencement of its commercial marketing in India. Although such order boosts availability of patented rare/new drugs and may give life to some back home but may put patients at the mercy of giant pharmaceutical companies. This also goes against the Agreement on Trade Related Aspects of Intellectual Property Rights, to which India is a signatory.

                It may thus, be concluded that there is always scope for improvement. The ease of sponsoring clinical trials in India is a good step but needs to be made friendly to the participants also as India has larger section of economically weaker lot. Besides, efforts should be made to improve transparency of the conduct of such trials and their results. 

Dr Mudasir Bashir Gugjoo is Assistant Professor, FVSc & AH, SKUAST-Kashmir