Chaos in Clinical Research

The recent irregularities reported in conducting of clinical trials by Axis Clinicals, a Hyderabad based CRO, in Andhra Pradesh has once again brought to focus the questionable ways in which clinical trials are being done in India by the pharmaceutical companies and their agents. The report said that the CRO conducted bio-equivalence studies for an anti cancer drug on poor women early this year without securing their informed consent. The episode came to light only last month when some women belonging to this group complained of severe body ache, joint and chest pain and extreme weakness after taking the drug. A few of them even had difficulty in walking. The office of the DCGI raided the premises of the CRO after report came in the media and suspended its license. Axis also will be disallowed from conducting all bio-availability and bio-equivalence studies at their centre for some time now. Investigation carried out by the DCGI officials found irregularities in procedures such as recruitments of subjects and in taking their informed consents. The DCGI also found that the ethics committee at the centre was not functioning independently as required under the existing ICMR guidelines. Many such violations by CROs while conducting clinical trials in India were reported in the recent past and actions were taken against the offenders. But, these offences keep occurring in various parts of the country and very few of them get reported in the media.

After the action taken against the Hyderabad CRO, the office of the DCGI decided to audit all CROs in the country to ensure that the bio-availability and bio-equivalence studies are performed strictly in accordance with the regulatory provisions and prescribed guidelines. The DCGI office has already completed auditing of CROs in Andhra Pradesh and Mumbai. The basic problem with the clinical research in the country is that the sector is not at all effectively regulated. The health ministry has been working for last ten years to put in place a set of comprehensive rules to regulate clinical research with huge flow of contract research jobs into the country. But that has not happened yet. Ethics Committees at most of the trial sites are not active with no monitoring of the trials. What the country has a set of guidelines after amendment of the Schedule Y of Drugs & Cosmetics Act and it is not yet notified. That is what emboldens the MNCs and CROs to conduct trials as they do it now. Now in the case of CROs, a set of draft rules for their mandatory registration was issued by the DCGI some time in July 2009 after it was approved by the Drug Technical Advisory Board. But the registration process is still not in place. The move to make registration mandatory for CROs was taken after finding a spate of irregularities in conducting trials in the past. In short, the slow decision making process in the health ministry is the prime reason for the whole chaos in clinical research front. The matter has to be taken up by the health minister seriously and urgently if this critical sector of the pharmaceutical industry has to function with some order.

Source: Pharmabiz

SALE OF BANNED DRUGS

Last week Pharmabiz reported about a series of raids conducted by the office of DCGI on pharmacy outlets in Delhi and Rajasthan for selling two of the banned drugs namely gatifloxacin and tegaserod. The officials stated to have seized huge stocks of the brands of these companies namely Lupin, Dr Reddy's, Sun Pharma, Cipla, Hetero Drugs, Torrent Pharma, Aristo Pharma, Intas and others. The inspectors of the Central Drug Standard Control Organization have conducted 135 raids in over 90 pharmacies in Delhi and Rajasthan. DCGI had banned gatifloxacin, an antibiotic and tegaserod, a chronic constipation drug for their adverse effects on last March 16. The order required the drug companies to withdraw their brands from the market with immediate effect. The decision to recall these drugs from the markets was on the basis of recommendations of the Drugs Technical Advisory Board. It is indeed surprising that these banned products continued to be sold in retail outlets even after three months of their ban. It is possible that the sales were taking place without the knowledge of the companies as most of the makers of these drugs are large and reputed companies. However, the manufacturers cannot pretend to be ignorant about such illegal sales of their products in the trade channels. Most of them have the monitoring system to track the sales of their products throughout the country.

Now, prior to the ban order of gatifloxacin and tegaserod in last March, DCGI had also banned drugs like nimesulide, cisapride, phenylpropanolamine and human placenta extracts for their adverse effects. These drugs have also been in the market for last many years and belonged again to large companies. The manufacturers, shortly after the ban, moved Madras High Court against the order and got an interim stay of the DCGI order and the case is pending in the court. CIPI, representing small drug units has, however, withdrawn its case against the ban from the Madras HC a few days ago. All these drugs have been already banned in developed nations, like the US, UK, Canada, Sweden, Denmark, Australia, New Zealand and Japan several years ago. What is being noticed in India for some time now is growing resistance from pharmaceutical companies to any withdrawal order from the regulatory authorities even if the drug is highly unsafe. One has to accept the fact that no drug is absolutely safe and all have side effects. Safety only means that the benefits of the drug outweigh the risks. Drug authorities worldwide grant marketing approval for drugs only after consideration of this principle of cost benefit. Continuation of marketing drugs with serious ADRs could be highly dangerous to the millions of patients who are taking them. Therefore, both the industry and trade have to cooperate with the regulatory authorities in withdrawing potentially harmful drugs from the market in public interest. And when the country’s most authoritative body recommends a ban on the basis of safety parameters, no pharmaceutical company has the moral ground to challenge such an action.

Madras HC postpones hearing on banned drugs case to April 26

The Madras High Court has once again postponed the hearing on the interim stay allowed by the court on banned drugs case on March 15. The next hearing on the issue will be held on April 26.

In the stay order dated March 15, the Madras High Court had allowed 15 days time to the drug companies to liquidate the stocks of nimesulide suspension and Phenylpropanolamine (PPA), which were banned in the country on February 10 this year by the union health ministry along with some other drugs that were found to make adverse effects on human health.

This is the second time the court has postponed the hearing in the case. Earlier, on March 31 the court had postponed the hearing to April 18 as the respondents, the health ministry and the DCGI, did not appear in the court on March 31.

Meanwhile, the postponement of further hearing on the case will give more time to the drug companies to liquidate their stocks of these banned drugs. A petition on this issue was filed by Confederation of Indian Pharmaceutical Industries (CIPI), an association of thousands of small pharma companies in the country.

Earlier on March 23, the court had merged this CIPI case with another similar case filed by pharma major Cipla Ltd.

Hearing the petition filed by Cipla on March 23, the Madras High court had stayed the entire notification of the ministry (GSR 82 E) dated February 10, 2011 in which it had banned six of the most controversial drugs in the country with immediate effect. These drugs included the non-steroid anti-inflammatory drug nimesulide (below 12 years age), gastroprokinetic agent Cisapride, decongestant drug Phenylpropanolamine (PPA), human placenta extracts, Sibutramine & its formulations and R-Sibutramine & its formulations.

In a gazette notification dated February 10, the ministry had banned these controversial drugs due to its adverse effects on human health.The ministry's decision in this regard was based on the recommendations of the Drugs Technical Advisory Board (DTAB), which is the highest decision-making body under the union health ministry on technical matters and its recommendations are normally followed by the ministry. Earlier, the DCGI had brought these controversial drugs under the radar of the DTAB in the wake of serious concern raised by the medical experts in the country over the side-effects of these drugs.