Chronic adhocism

Written by Soma Das | Updated: May 31 2012, 08:05am hrs
The Drug Controller General of India (DCGI), the top job in the countrys drug regulatory space, remains mired in a legal mesh and steeped in chronic adhocism at a time when the Central Drugs Standard Control Organisation, better known as DCGIs office, has turned into an eye of a storm triggered by a parliamentary panel report. The report hurls serious accusations at the DCGI office, stating some officials over the years have been colluding with pharma companies and doctors or medical experts to ensure unhindered approval of new drugs that companies wish to market.

The three-month term of Gyanendra Nath Singh, who was given the additional charge of DCGI in February this year along with his current responsibility as secretary-cum-scientific director of the Indian Pharmacopoeia Commission, ended on May 21 and, though he continued to look after day-to-day work, an official order renewing his extension only came on Wednesday (May 30), albeit with retrospective effect from last Monday (May 21).

For seven months now, since the former DCGI Surinder Singh relinquished office, the country has had a stop-gap arrangement for the top position in the central drug regulators office. The health ministrys endeavour to appoint a DCGI for the country through a UPSC selection process has run into litigation. GN Singh was the preferred choice of a UPSC panel for the drug regulators post but multiple litigations scuttled his regular appointment.

This neglect of the DCGI office, which holds significant sway over the R60,000-crore domestic drug market, may come as a surprise to many but is hardly new. Barring a three-and-half-year-old stint of Surinder Singh from April 2008 to October 2011, the country has not had a permanent DCGI for almost a decade since 1999. During 1999-2008, two successive DCGIs, Ashwini Kumar and Venkateswarlu, held additional charge of this key post. This current phase of uncertainty is a reflection of the historical adhocism and the utter neglect that this office has been subjected to for a long time.

The current legal row

At the heart of the current turmoil is an insider-outsider tussle, wherein a section of the current lot of senior staff at the DCGI office feels discriminated against for not being considered seriously for the top drug regulators position. Dilip Kumar, secretary of Indian Pharmacy Graduates Association, who first challenged the recruitment procedure in Madras High Court and managed to get a stay on the recruitment, alleges that recruitment rules on criteria including age were tweaked by the health ministry to suit their preferred candidate. His main crib is that the national drug regulators job is turning into a deputation post which jeopardises the promotional prospects of the cadre who work their way up.

A lawyer points to the other side of the story. The senior-most official in the current DCGI office is still a deputy drug controller and will become eligible for the post of joint drug controller not before 2015. It is only after spending a few years as joint drug controller that can he rightfully contend for the post of drug controller without seeking any concession. By then, the current DCGIs tenure would have run out. So where is the question of promotional prospects getting jeopardised This is a question the countrys courts will answer.

The stay granted on the recruitment by Madras High Court was subsequently vacated by a multiple bench of Madras High Court. Kumar appealed against the order and filed a contempt of court petition in the Supreme Court against the appointment of GN Singh as DCGI by the Union health ministry on February 21 this year. The Supreme Court upheld the stay granted by the Madras High Court and would hear out the merits of the case in early July. The governments side of arguments may be presented by Solicitor General Rohinton Nariman.

Getting entangled in legalities of service matters is becoming habitual for this post, considering the exit of former DCGI Surinder Singh in October 2011 was also primarily prompted by such issues. The parliamentary panel has now rightly sought revision to the ancient qualifications criteria which prescribe a graduation in pharma chemistry as the minimum eligible criterion for the post of DCGI. The panel thinks, this and a few others keep some of the brightest doctors away from the drug regulatory office.

The price of adhocism

When adhocism becomes a normal state, the country pays a price for it. So does it come as a great surprise that the DCGI office failed a WHO inspection (national regulatory authority assessment) in 2007 causing much embarrassment to a country hailed as the pharmacy of the world!

Such has been the sloppiness in the maintenance of files at the central drug regulators office that when the parliamentary panel sought detailed data regarding drug approval processes since 2003, the DCGI office could only furnish data from the start of 2008. This could well be the secret behind the missing files of the DCGI office. At a time when the central drug regulators office receives almost 55,000 correspondences annually, it must devise a systematic and orderly way to preserve important documents or better still move most such storage online like many of its counterparts in regulated markets have done. And it is difficult to develop a vision, leave alone implement it when the chief of drug regulatory agency has to wait for a renewal every three to six months, as has been the case in most parts since 1999.

A competent regular central drug regulator is the least the country can expect from the government. Having a regular DCGI certainly helps.

Although the tenure of the only regular DCGI in the last decadebetween 2008 and 2011was far from smooth sailing, the country did witness many firsts during this period. For instance, the setting up of a national pharmacovigilance programme to scientifically monitor side effects of drugs in Indian population, conducting overseas inspections at the facilities from where drugs are exported to India, a countrywide survey to assess the extent of spurious drugs, conducting joint raids with CBI in different states to unearth spurious drugs, creating 12 specialised new drug advisory committee with 120 doctors on the panel to examine applications for clinical trials and drug approvals are some of the initiatives taken during the time when the country had a regular DCGI.

In fact, in December 2011, Nata Menabde, the India head of WHO, told FE that there has been some major breakthrough in the Indian drug regulatory landscape since 2007. She acknowledged that at least the central office (DCGI) has put its act together, the government has pumped in resources, invested in the regulatory structure and the DCGI office has taken many initiatives on several fronts to catch up with global benchmarks, and these efforts are definitely showing results. What really worried her at the time was the fledgling health of state drug regulators. Also, towards the end of 2008, WHO appreciated the fact that India had followed and monitored the roadmap decided upon. But only when it seemed that things were brightening up for the central drug regulator, the parliamentary panel reckoned that all may not be well with the office despite all these recent steps. More so, against this backdrop, can the country afford to continue with this adhoc leadership for long, particularly when the central drug regulator is expecting the next WHO inspection as soon as the end of this year

Acute resource crunch

An uncomplicated comparison of budget (not adjusted for purchasing power parity) and people strength of the Indian drug regulator with some of the worlds most followed drug regulators can help us assess the standing and strength of our own.

Compared to a budget of $2.5 billion of the most robust and referred US Food and Drug Administration (USFDA), the sanctioned budget of the DCGI office last financial year was a paltry R24 crore. While USFDA has a staff strength of over 11,500, with specialisation in different streams, the DCGI office has an employee strength of 119 (May 2012), as against an approved strength of 327. Even this seems an improvement over 2008, when the office actually had 64 people, as against approved posts of 111. Even the drug regulator of the UK, with much lower population than India, spends well over R600 crore (2010-11 estimates) and employs over 900 people. Australias drug regulatorTherapeutic Goods Administrationhas 500 full-time employees, while Japans Pharmaceuticals and Medical Devices Agency boasts a staff strength of over 640. This stresses the attention the central drug regulators office receives in our country.

Also, in the all-so-important annual meeting of the Union health minister with state health ministers, drug regulation as an agenda never figured before last year, indicating the priority attached to issue. This, when a large chunk of governments healthcare expenditure is spent on procuring drugs for national health programmes.

A latest Lancet report dubs the Indian central drug office dangerously understaffed. Nine officers at the headquarters struggling to deal with 20,000 applications, over 200 meetings, 700 parliamentary questions, and 150 court cases per year is a recipe for disaster. Adding to the woes is the dearth of medically-qualified staff, poor support infrastructure, lack of coordination between departments, and a scarcity of decent computer systems, Lancet reckons.

Pouring scorn over an ailing organisation at a time when it is in urgent need of medical help is hardly a solution. In the short run, if the government wants to avert the shame of central drug regulator failing another WHO inspection, it must correct these two fundamental lacunaeadhocism in leadership and resource crunch. For the long term, if the country is serious about its aspiration to be recognised as a source of very safe and qualitative medicine, it must nurse back to full health the chief guardian of drug safetythe DCGI office.