SpicyIP Tidbits: Indian Drug Regulatory System Forced to Swallow the Bitter Pill by WHO

The Indian drug regulatory system is at the receiving end of a withering scorn from the WHO which lambasted the Indian authorities for the lackadaisical approach which pervades the drug approval mechanism. Coming from the WHO, these scathing remarks are extremely damaging for a nation which boasts of being home to the world’s fourth largest pharmaceutical market by volume and thirteenth by value and probably point to the need for some honest soul searching.

What is even more dangerous is the observation by WHO that the “Indian drug regulatory authority is not independent and is functioning under pressure”. According to PharmBiz:

“The WHO has also taken strong objections to the new drug approval mechanism existing in the country. The WHO team expressed surprise over the way new drugs are approved in the country without proper documentation on pre-clinical, clinical and toxicological studies. The WHO national regulatory appraisal team, which held a series of marathon meetings with the health ministry officials, raised thousands of questions on several issues concerning the quality of medicines and drug regulatory system in the country, sources said.”

Further, it appears that the Indian health ministry was hauled up earlier this year by the WHO. PharmaBiz reports:

“Earlier this year, the WHO had asked the health ministry to either suspend the licenses of four government-owned vaccine manufacturers, Haffkine Biopharmaceuticals in Mumbai, BCG Vaccine Laboratory in Chennai, Pasteur Institute of India (PII) in Coonoor in Tamil Nadu and the Central Research Institute (CRI) at Kasauli in Himachal Pradesh or upgrade the quality of these institutes. The government had already closed down the latter three institutes.”

PharmaBiz added that WHO has asked the Indian health ministry officials to undergo training in an advanced country to understand how the regulatory system works in those developed countries. Under the WHO direction, an Indian health ministry team, including Drug Controller General of India (DCGI) Dr Surinder Singh and joint secretary in the health ministry Devashish Panda, is leaving for Canada on April 26 for a week-long training. The Indian health ministry officials will study the regulatory system in Canada, especially the new drug review procedure, and how it can be adopted in Indian scenario.

The malady is deep rooted with an urgent need for long-term measures and an absolute contempt for myopic solutions. This is evident from an article in ExpressPharmaOnline in 2002 where it was reported as follows:

‘‘Applications submitted to the DCG(I) for permission for clinical trials in respect of new drug applications (NDA) and abbreviated new drug applications (ANDA) are often referred to outside agencies like the Indian Council of Medical Research (ICMR) and the Department of Biotechnology, Government of India (DBT) for review. This arrangement often leaves very little control with regard to the time runs.’’

The reason for this “outsourcing” is again given by PharmaBiz which cites the case of State Drug Regulatory Authorities:

“In most of the states, they are under staffed and no established systems are present. They are technical and professional (Pharmacy) in nature. We cannot expect technical expertise with policing from one person. There are three aspects to be observed by State DRA: 1. Regulate the manufacture of the drugs in their area to meet the specifications and guidelines laid down by the Drugs and Cosmetics Act, 1940 and Rules 1945 2. Regulate the Inter and Intra state Commerce in Drugs 3.Prevention, Control and take steps to punish the offenders. In case of first aspect, most of the states are very week and a few states are implementing, as they like. Some times, they are overlapping in to the authority of DCGI in permitting new drugs. There are hardly any regulations or control over the mistakes or offences committed by the State DRA Officers who permit even manufacture banned or new drugs. Except Maharastra and Gujarat, all other state DRA’s are not strong in respect of finance or mechanisms or facilities provided by the State Governments. The budget allocated to DRA in any state is not even 0.4% of their health budget. In this, nearly 86% is going to the staff salaries and only 10% is going to be spent for actual work. States are not showing much interest in implementation of this Act and Rules as it is a Central Act. Any happenings are threatening to the existence of their continuity (political) then only they are showing concern for implementation of this act. In many States, Local political personal are trying to interfere in the implementation of this Act and rules. Local persons are influencing the DRA officers and the bad activities in this field are posing threat to the nation’s health in the form of spurious / adulterated etc. drugs. In view of this, some of the category of drugs manufacturing licenses is getting approved by CLAA.”

Again budget and manpower seem to be the predictable reasons as is the case with other government agencies including the Patent Office. Hopefully, the powers that be in collaboration with the players come up with a mechanism on the lines of the USFDA or the one in the EU.