Be it approval of drugs, their ban or clinical trials, a regulatory upgrade is the only catalyst that can breathe new

life into the pharma industry

When a parliamentary committee on health had submitted in its report in May 2012 that the Drug Controller General of India (DCGI), responsible for the regulation of drugs and medical devices, had been approving drugs without requisite clinical trials and expert medical opinion, leading medical journal The Lancet had suggested in an editorial that India would be better off with a new drug regulatory body instead of trying to overhaul an organisation ?that is failing so catastrophically?.

Cut to April 2013. With the same parliamentary committee pulling up the health ministry for ?paralytic inertia? on its findings of irregularities, the functioning of the DCGI has come under a scanner.

And while the view in India is not as radical as that of The Lancet?s, there is unanimity on the need for a regulatory breakthrough. Says DG Shah, secretary general of Indian Pharmaceutical Alliance (IPA), ?We need both an overhaul of the drug regulator, as well as improvement in regulatory efficiencies to make the regime more effective. We need an efficient process so that drug regulation is transparent. For instance, when an application is submitted, a time limit should be set, say of 30, 45 or 60 days, for the regulator to reply to that application. Also, there should not be any shoddy examination of the application; a decision should be taken only after a thorough review of all aspects and data.?

He adds that elevating the office of the DCGI to the level of secretary or additional secretary level is necessary. In the US and UK, the drug regulator is at least of the level of a joint secretary. Moreover, he feels defining the scope of responsibility and authority of the Central Drugs Standard Control Organization (CDSCO) is necessary. ?Currently, the health ministry has all the authority without the responsibility, whereas the CDSCO has all the responsibility without the authority to take decisions,? says Shah.

Agrees Dr Venu Gopal Jhanwar, a psychiatrist at Deva Institute of Healthcare & Research, Varanasi. ?I don?t think a new regulator is needed. However, the same team?s functioning needs to change and processes (of drug approval and clinical trial approval) need to be re-evaluated.? He adds that the new drug approval committees should have members from different walks of society to get the right perspective.

The malaise

The panel of MPs, headed by Bahujan Samaj Party lawmaker Brajesh Pathak, which had conducted an audit on the system of granting drug approvals by the CDSCO for 18 months between 2010 and 2012, found an ?overwhelming? majority of medicines (out of a random sample of 42 drugs) being certified for sale on the basis of personal prescriptions and without any scientific evidence.

The standing committee found that 33 new medicines had been approved between January 2008 and October 2010 without undergoing human trials. In case of the randomly picked drugs, it was found that in case of 11 drugs, mandatory phase-III clinical trials were not conducted.

The report of this parliamentary panel, released last year in May, opened a Pandora?s box of ?casual approach, unethical steps and illegal measures? taken by the regulator, drug companies and doctors to push for introduction of certain drugs in the market.

In an attempt to nullify the ?storm? created by the parliamentary standing committee, the health ministry, in its action taken report (ATR), submitted in December 2012 that it had changed its mission statement to: ?To safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices? from the earlier ?To meet the aspirations… demands and requirements of the pharmaceutical industry?.

Not surprisingly, the parliamentary panel had found ?sufficient evidence? to establish a collusive nexus between medical experts, drug companies and CDSCO officials.

There have also been several reports of damaging gaps in clinical trials in the country, with numerous cases of deaths and disability.

Health and welfare minister Ghulam Nabi Azad had submitted in Parliament in March this year that the number of deaths in clinical trials reported during the past three years (2010, 2011 and 2012) were 668, 438 and 436, respectively, while deaths attributable to clinical trials were 22, 16 and 16, respectively, during these three years. he said.

The health ministry had explained in December that as per the rules, the DCGI has the power to approve drugs without clinical trials in ?public interest?. The parliamentary committee, however, said in April, ?No explanation is available as to what constitutes public interest. How can approvals given to foreign drugs without testing on Indians be in public interest? Some of the reasons given for irregular approvals are ?serious disease? (all the more reason to conduct clinical trials to ensure that patients in India really benefit from such imported, exorbitantly expensive drugs) and ?rare disease? status according to the US-FDA (how can US-FDA decide which is a rare disease in India?).?

In cases where foreign drugs were approved without clinical trials in the country, the ministry said in the ATR, ?Most of the drugs are approved in other countries based on multinational clinical trials on various ethnic/racial populations.? The parliamentary panel in its remarks had retorted, ?This is implying that Indians would be included and hence conducting trials in India was not necessary. However, this presumptive remark is not accompanied by any evidence.?

The controversy surrounding the clinical trial environment in India has pharma companies and contract research organisations (CRO), who conduct clinical trials, worried. ?The clinical trials situation in India is worrisome. Only six studies have been cleared by the DCGI in 2013 so far, while last year, over 260 studies were approved,? said a spokesperson of domestic pharma major Biocon, which has a strong CRO arm.

Soon after being reprimanded by the Supreme Court in January 2013 for ?failing to take proper note of the legal and ethical ramifications of clinical trials?, the health ministry ruled compulsory registration of ethics committees and regular monitoring of clinical trials. Rules relating to compensation for injury and death were also framed to include payments for the immediate and long-term medical treatment of injuries sustained, compensation for disabilities, and payments to heirs in death cases. However, the industry feels that this has led to the ?shackling of clinical trials?. India was well placed to be the largest clinical research hub of Asia, ?but if we curtail clinical trials and global pharma companies move to China, South Korea and other east and south Asian countries?as they are doing?we will only end up hurting Indian patients?, feels Biocon.

The treatment

?The need of the hour is a strong regulatory mechanism and political will to ensure that safe and effective medicines are approved for the general populace,? says Dr Gopal Dabade, ENT surgeon in a Karnataka-based hospital, and co-convener of the All India Drug Action Network (AIDAN).

The health ministry had also stated in its ATR in December that it has set up various expert committees and sub-committees to guide the DCGI ?in matters related to regulatory approval of new drugs, clinical trials and new medical devices?. It had added: ?The situation is still evolving and will be a continuous process?.

However, this only led to the parliamentary panel in April blaming the government for ?dilly-dallying and procrastination? regarding the sale of banned medicines and failing to stop the marketing of 33 drugs that were approved without clinical trials, in response to the health ministry?s ATR.

To be fair to the regulator, the CDSCO has remained ?dangerously? under-staffed over several years. Only nine officials at the headquarters deal with 20,000 applications, more than 200 meetings, 700 parliamentary questions, and 150 court cases per year. There is also a dearth of medically qualified staff, poor support infrastructure, a seeming lack of coordination between departments, and a scarcity of decent computer systems.

However, the committee had observed in May last year that strengthening of the drug regulatory mechanisms cannot be achieved by manpower augmentation alone. ?A host of issues involving capacity building of the CDSCO like upgrading existing offices, setting up new offices, creation of new central drugs testing laboratories, skill development of regulatory officials, implementation of an effective, result-oriented pharmaco-vigilance programme will have to be addressed before the desired objectives are realised,? it had proclaimed.

A government-appointed, high-level expert group had also recommended that the health ministry ?should be empowered to strengthen the drug regulatory system? to move India towards universal health care, as part of the 12th Plan.

The Lancet in its editorial had suggested that a smooth-running, professional drug regulatory body is essential to ensure that high-quality, adequately assessed drugs are available to India?s population and that India?s drug industry is regulated well enough to contribute successfully to India?s domestic and export sectors.

The R70,000-crore domestic pharma sector is poised to grow between 11% and 13% this year, according to projections by pharma market research firms. Moreover, a new report from India Ratings in February this year states that the country?s leading pharmaceutical players will continue to experience revenue growth of over 20% this year, primarily led by exports, especially to the US.

The report also sees continued good growth for Indian-made generics in other developed and ?pharmerging? markets, due to patent expiry and cost-cutting measures by payers. On the back of this increasing demand, exports now account for 60% of the Indian pharma sector?s total revenues, which grew by an annual average of 19% between 2008 and 2012. In January-October 2012, Indian drug exports were worth R620 billion, an increase of around 28% year-on-year. ?We expect this trend to continue,? says India Ratings, a Fitch Group company.

Clearly, a strong hand that can implement rules while maintaining the balance between growth and ethical practice is the need of the hour.