The ongoing litigation before the Delhi High Court over the ban of 344 fixed-dose combinations is forcing the spotlight on to the murky world of drug approvals in India. FDCs, as the name suggests, is a combination of existing drugs into one potent formulation.

While there is undoubtedly some medical rationale for the concept, — for example, it helps to increase patient compliance with taking medication — the thousands of FDCs in the Indian market are fuelled primarily by the desire to evade the Drug Price Control Order (DPCO).

Since the early 1980s, the medical community has been publicly calling on the Drug Controller-General of India (DCGI) to crack down on FDCs because several lacked basic medical rationale and were being marketed without any supporting clinical evidence.

Every time the Centre notified bans on certain FDCs, the pharmaceutical industry took the government into a neverending abyss of litigation. In the last FDC ban notified in 2007, the Centre had banned 294 FDCs; the industry promptly got an interim stay from the Madras High Court — the matter is yet to be disposed nine years later.

Despite the Supreme Court settling the law, in the case of Systopic Laboratories (Pvt) Ltd v. Dr Prem Gupta (1994) AIR 205, on the Centre’s power to ban even those FDCs which have been in the market for several years, High Court judges continue to indulge the pharma industry’s lawyers with interim stays and longwinded hearings during which the industry continues to distribute its existing stock by peddling the poison to the citizens of this country.

How are they approved? The more pertinent question to ask is how are these FDCs being approved in the Indian market in the first place? Typically, before a drug is approved, it is required to be supported by clinical trials conducted by independent medical experts. If the Government is now banning these drugs, clearly there never was any evidence to support their use to begin with.

How then were the approvals granted? These are not new questions — FDCs and other drug approvals in India have been plagued with irregularities which the government has refused to investigate even after being hauled up by the parliamentary standing committee on health.

The 59th report of the committee, tabled in 2012, had discovered a shocking collusion between the drug regulator, the industry, and medical doctors in the approval of a set of drugs: buclizine, letrozole, an FDC of flupenthixol and melitracen (Deanxit), and an FDC of aceclofenac and drotaverine.

The committee noted that most of these drugs had received approval in the Indian market despite the fact that advanced jurisdictions such as the US and the EU refused similar approvals. When the standing committee sought the files from the DCGIs to understand the basis on which these approvals had been granted, the Government simply didn’t cooperate.

In the case of the approval for Deanxit, the standing committee noted “Except for giving file number (12-62/95-DC) and the date of approval (28-10-1998), the Ministry failed to provide any documents and information on the regulatory process that led to its approval (such as import permission, mandatory clinical trials etc.).”

After listing the several obvious defects in the approvals process, it observed “The Committee is of the opinion that there must be some very good reasons for Danish Medicine Agency (Denmark) not to approve a domestically developed drug where an anti-depressant drug would perhaps be in greater demand as compared to India. Curiously, Deanxit is allowed to be produced and exported but not allowed to be used in Denmark.”

It’s a racket Similar observations were made with regard to all the drugs mentioned above — in some cases it was clear that even medical doctors were involved in this racket. Commenting on the nature of these approvals, the committee concluded: “There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts.” The committee also demanded the ministry of health and family welfare investigate the manner in which these approvals were granted because there was prima facie evidence of wrongdoing in granting these approvals. In typical bureaucratic fashion, the ministry set up an expert committee under VM Katoch to study the committee’s report. The expert committee agreed with the recommendation of an investigation into the shady approvals.

On December 28, 2012, the ministry submitted an ‘action taken report’ to the standing committee promising an investigation into the manner in which these approvals were granted.

However, no action was taken and in the 66th report tabled in Parliament on April 26, 2013, the committee noted its shock at the inaction of the ministry. In the case of the buclizine approval, the report observed: “The Committee takes serious umbrage over these more than apparent dilatory tactics being adopted by the Ministry to somehow delay action against the wrongdoers.”

And for the approval of letrozole for an additional indication, the report notes: “The Committee finds it deeply perturbing as to why the Ministry has failed to take action in this very open and shut case of impropriety and criminal lapse. Though more than six months have elapsed, the Committee strongly feels that if perpetrators of such illegalities and collusive acts which are detrimental to public health are allowed to go scot-free, then the total collapse of an ethical health care system is inevitable.”

With respect to Deanxit, it said: “If any drug is promoted for unapproved indications, DCGI has the statutory duty to take action and even cancel marketing approval. The Committee is aghast that no action was taken against the Danish manufacturer, Lundbeck even when it was openly flouting Indian laws. Compare the lack of action in India with the United States where for a similar offence Pfizer had to shell out Rs 2,300 crores for promoting gabapentin for an unapproved indication.”

No inquiries My attorneys filed applications under the Right to Information Act, in late 2015, in order to establish whether the Government investigated the manner in which approvals were granted. We received answers in the negative; the MOHFW did not initiate a single inquiry into this matter. Faced with such unfathomable levels of unaccountability, I had included this as one of the many issues in the PILs that the Chief Justice of the Supreme Court refused to admit last month on the grounds that the PIL raised academic issues.

Regardless, the citizens of this country deserve an investigation into how approvals for these FDCs and the drugs mentioned by the standing committee were granted in the first place. Was it corruption or incompetence that led the bureaucracy to jeopardise the lives of citizens? Such an investigation cannot be either fair or independent if it is conducted under the aegis of the ministry of health. This is precisely why I had requested an independent commission headed by a senior advocate of the Supreme Court to investigate this matter. It is only when we fix the responsibility for these illegal approvals that we can prevent a repeat in the future.

The writer is a senior pharma sector executive who was the whistleblower in the Ranbaxy US FDA case

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