Why drug approval system should be made transparent

In an ignominious event which may have marred the reputation of the entire drug regulatory system in the country, the joint drug controller (JDC), posted at the Central Drug Standard Control Organisation (CDSCO) Headquarters in New Delhi, S Eswara Reddy, along with some others, was recently arrested by the Central Bureau of Investigation (CBI) on charges of corruption

In an ignominious event which may have marred the reputation of the entire drug regulatory system in the country, the joint drug controller (JDC), posted at the Central Drug Standard Control Organisation (CDSCO) Headquarters in New Delhi, S Eswara Reddy, along with some others, was arrested by the Central Bureau of Investigation (CBI) on charges of corruption.

On June 20 this year, the CBI arrested Reddy and a director of a private company based at Delhi in an alleged bribery case of Rs. 4 lakh. According to published reports, the country's premier investigation agency apprehended Reddy, one of the senior most officials in the country's drug regulatory administration and former Drug Controller General of India, after raids conducted at the headquarters and other places. The agency said that a case was registered against the JDC and others including directors, Associate Vice President and Head-National Regulatory Affairs (NRA) of separate private companies, two based at New Delhi and another at Bengaluru; Assistant Drug Inspector (ADI), CDSCO, New Delhi and other unknown officials of CDSCO, New Delhi and unknown others. The CBI alleged that the accused was trying to exert undue influence on officers of CDSCO under the Directorate General of Health Services, Ministry of Health & Family Welfare to waive the phase III trial of a drug. It was further alleged that the accused agreed to pay a bribe amount of Rs 9 lakh to JDC, CDSCO for favorably processing the files related to the private company for waiving the phase III trial of the drug. Earlier in August, 2019, the CBI had arrested Dr Naresh Sharma, Deputy Drug Controller of CDSCO for charges of corruption.

The incident has opened the proverbial Pandora's Box of corruption in the drug approval system in the country. In fact, the health experts and industry association leaders have long been calling for more transparency in the drug approval system and the overall drug regulatory framework in the country. The arrest of Reddy and others reminds about the recommendations of the 59th report of the Department Related Parliamentary Committee for Health and Family Welfare, on the operations of CDSCO. The panel had found several discrepancies in the drug approval system and it had directed the government to address the issue on a priority basis. The report also called for greater transparency in the appointment of the expert committee and the approval process of the drug regulatory authority in the country. It is true that in India, every discussion and document is confidential and away from public scrutiny while in the US, the opinions and decisions are in public domain so that anyone is free to scrutinise, offer comments and give suggestions. The CDSCO's work is completely opaque and there is no transparency in the working of the organization. In the present CBI case, the CDSCO official was ultimately supposed to take the application for the waiver of the phase III clinical trial to the Subject Expert Committee (SEC) of the CDSCO, whose members are from outside. But nobody knows who the members of the SEC are as the names are never made known. Besides, the SEC discussions are not reported in the minutes of the SEC meetings as only the decisions are made public. The reasoning on why the SEC members have taken a certain kind of decision is never made public. This kind of lack of transparency leads to all kinds of deals and corruption in the drug regulatory system.

Definitely, this matter needs to be reviewed to ensure safety of patients, fair play, transparency and accountability. The best way to fight corruption is to open up the entire drug regulatory system in the country. Let all the information be available in the public domain and let the people question the experts who are giving the opinion. The Parliamentary Standing Committee has rightly asked for a few things like putting up the recommendations of all the members of the expert committee, so that anybody will know who said what and who voted how and how much homework these experts have done. It is to be noted that many of these studies run into thousands of pages and it is unlikely that the SEC members would have read it completely. So, the time has come the government heeds the recommendations of the Parliamentary Standing Committee and makes the entire drug approval system and other regulatory systems transparent. It is in the overall interest of the pharmaceutical industry and the patient community in the country.

(The author is freelance journalist with varied experience in different fields)