Drug bust

Written by Soma Das | Updated: May 15 2012, 07:22am hrs
A parliamentary panel report tabled last week exposed fundamental flaws in the process of drug approval. It attacks all stakeholders involvedthe regulators office, the pharma companies and the doctors who act as medical experts and recommend the approval of a drug without proper testing. If the panels random sample is representative of the state of affairs, it would be a gross understatement to call the extent of collusion and oversight as shocking.

With reference to the litany of accusations hurled at the drug regulators office in the last few days, are these acts of omission and commission new

No. The revelations may be shocking but the timeline chosen by the panel for investigation itself spans over a decade from 2001 to 2010, during which the regulator approved over 2,000 drugs. The long duration under consideration exposes the systemic nature of slippages on part of the office of the Drug Controller General of India (DCGI). Some cases date back to the 1990s. For instance, anti-depressant Deanxit, the very approval of which is being questioned now, gained a green signal way back in 1998. In the meantime, the marketing rights have changed hands in the country. While the clearance was originally bagged by a company called CFL Pharma, the drug is currently being marketed by a Danish company Lundbeck.

What is the exact nature of problems cited by the panel Who is being held responsible for the transgression

The panel is enraged by the arbitrary and whimsical manner employed to approve drugs in the country. The panel enlists three broad sets of misconduct in the drug approval process. First, the DCGI office has absolved many new drugs from mandatory late stage clinical trials. These include drugs from reputed foreign MNCs such as Novartis, GSK, Eli Lily as well as top domestic drugmakers such as Cipla. DCGI may have done this by invoking the public interest clause in the law that the panel thinks was meant to be reserved for emergencies such as swine-flu or SAARS. The second lapse relates to laxity in approving clinical trials based on which drugs are approved. But it is the third set of blunders that is most disturbing: a possible nexus between some DCGI officials, pharma companies and specialist doctors from reputed institutions including AIIMS (New Delhi), CMC (Vellore) and PGI (Chandigarh) who have seemingly colluded to ensure unhindered approval of a new drug. In some cases, these medical experts located miles apart have shot off identical letters to recommend the approval of drugs and clinical trials. Responsibility must be fixed by identifying officials involved in specific cases, doctors who have signed off these letters and the drug firms that have been the beneficiaries.

Are such improprieties by the drug regulator and pharma companies restricted to the drug approval process

Although a large part of media coverage of the report may give such an impression, the truth is lesser evils are getting buried under the weight of greater blunders. Does the responsibility of a drugmaker cease once it discovers a drug by proving its safety and efficacy through clinical trials, obtains mandatory regulatory approval and then starts marketing the drug Far from it. The company has a duty to monitor whether the drug causes serious side-effects through studies called post-marketing surveillance. This is how anti-obesity drugs sibutramine and rosiglitazone got banned in regulated markets. Also, evolved drug regulators such as the US Food and Drug Administration follow practices such as offering a phone number on which any one can call and report an adverse event. The panel found drug companies skimping on this account by not submitting these data. This deprives DCGI of critical data on adverse effects on people of different ethnic profiles in this country. Most foreign companies that have submitted such data have not given India-specific data, thus defying the purpose of such an exercise. Also, the Indian drug regulator was found wanting while banning drugs that have been barred from use in most regulated countries. On DCGIs own admission, under a World Bank-funded programme (November 2004 to June 2008) to detect side-effects, not a single new adverse drug was reported from India. The committee reels off examples like Analgin that have been banned in countries like the US and France but are yet to be phased out here. The committee asks the DCGI to track developments of other regulators and take prompt measures.

How do countries like the US and the UK decide which drugs to ban

These countries mandate and analyse post-marketing surveillance data submitted by pharma companies very seriously. Also, they run pharmacovigilance programmes to monitor adverse impact. India has also set up a similar programme in 2011 with AIIMS as its node and aims to connect it to a network of all medical colleges but the scheme is yet to gather full steam. Insisting on India-specific post-marketing data from companies and strengthening the pharmacovigilance system can empower DCGI to take decisions based on Indian data rather than depend only on external data.

Most allegations are levelled against the central drug regulators office Whats the verdict on state regulatory authorities

A gaping hole in the drug regulatory structure is the lack of coordination between the drug regulatory authority at the Centre and at the state levels as well as lack of communication between state regulatory agencies. This leads to avoidable problems. For instance, new drugs are approved by the Centre under their generic names. Brand names are communicated by the manufacturers to state drug authorities. Due to lack of coordination between various state drug regulators, many identical brands are being used for different medicines by various manufacturers located in different states. For example, Lona is being used for low sodium salt as well as for clonazepam (anti-epilepsy drug); AZ brand is being used for azithromycin (antibiotic), albendazole (for worms) and alprazolam (for anxiety), a practice which can create dangerous confusion. Also, some state drug regulators have issued manufacturing licences for a very large number of combination drugs without prior clearance from the central regulator. This has led to the market being flooded with drugs that have not been tested for efficacy and safety. This is a problem unique to the Indian market. While the functioning of the state drug regulators remains outside the scope of this study of Parliament, according to the health ministrys own admission, it is a matter of serious concern.

Has the parliamentary report addressed all areas where the Indian drug regulatory structure needs correction

The report, though exhaustive, doesnt cover all the lacunae in the drug regulators working in totality. For instance, India doesnt yet practice a transparent drug recall mechanism, through which when a pharma firm or a regulatory arm discovers that certain batches of drug in circulation are either contaminated or do not meet packaging or labelling norms or have other quality issues, they can order withdrawal of these batches from the market with immediate effect. For this, several agenciesthe central regulator, state level regulators, pharma companies and pharmaciesmust work in tandem. But these practices are intrinsic to regulated markets such as the US. There, each drug recall is classified on the basis of seriousness and made public on the regulators website. Such steps risk the reputation of pharma companies and make them accountable for the quality of drugs supplied. Frequent recalls can invite the wrath of regulators, who may choose to act stringently against serial defaulters.

What has come off the report

After wide coverage in the media, companies named in the report have promptly denied any wrongdoing. Foreign MNCs Novartis, GSK, Bayer as wells as domestic firms Sun Pharma and Cipla have stated categorically that they have not deviated from the law of the land. The health and family welfare minister has constituted a panel of experts to look into alleged irregularities in granting approvals to new drugs. The panel is expected to submit its report within two months. We needs urgent reforms in drug regulation so that India can travel the distance from being a semi-regulated drug market to a regulated market.