Clinical trials: DCGI faults 9 more CROs

HYDERABAD: Nearly a month after the licence of Axis Clinicals was suspended for irregularities in conducting trials on poor illiterate women, officials of the Drug Controller General of India (DCGI) found similar violations by nine Clinical Research Organizations (CROs) in the state. Highly-placed sources said that there are glaring violations in the recruitment process of `subjects' and in taking their informed consent in almost all these organizations, where the gullible are becoming guinea pigs.

In fact, Actimus Bio Sciences, Visakhapatnam, which is the latest to get embroiled in the clinical trial controversy, was one among the eight CROs recently inspected by the DCGI officials.

It was after Axis Clinicals was found to have administered anti-cancer drug to poor women from Piduguralla in Guntur district without securing their consent in June this year, DCGI had decided to investigate the working of all bioavailability and bioequivalence study centres in Andhra Pradesh within a period of two months to ensure that such studies are performed strictly in accordance with the applicable regulatory provisions and prescribed guidelines.

The officials, who are yet to submit the final report to DCGI, Delhi, revealed that they concentrated on the issues pertaining to the recruitment process and the ethical committee's approval process adopted by these CROs during their course of investigations. "None of them is fully following either the guidelines of the Indian Council for Medical Research or the rules framed in the Schedule Y, which are necessary for manufacturing new drugs," said an official adding that some documents were seized during the investigation.

Besides, the Standard Operating Procedure drafted for every study was given a go by. "They should practise and follow what is there in the SOP. Further, if video recording of subjects is done prior to the study, it would be beneficial for these organizations though it's not mandatory. None of them is adopting this practice," said the official adding that more than 50 studies are being done annually by these CROs.

Aizant, Sipra, Bio Serve, Vimta, CR Bio, Nicholas Piramal, GVK Bio are the other CROs operating in the state. The DCGI officials said that the final report would be submitted to DCGI in about a week or so. He added that a team would again visit Actimus Bio Sciences in Visakhapatnam on Wednesday to study the case of two students who were subjected to clinical tests for two days.

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Anti-Anxiety drug to be banned in India

The government is planning to ban a popular Anti-Anxiety drug that has been commonly used in India for over a decade. The drug is used without any clinical trials and despite the fact it is banned in several other countries. 

TIME magazine describes this decade as the "Age of Anxiety" and 4 out of 10 Indians suffer from anxiety related disorders according to the Indian Council of Medical Research.The Health Ministry is considering a ban on the commonly-used anti-anxiety drug Deanxit, for potential addiction and because it can sometimes provoke suicidal thoughts and nightmares.Psychiatrist, Bombay Hospital Dr Sharita Shah, said "In India, its not just psychiatrists who are using it, there are a lot of other doctors, like the GP, cardiologists, everyone prescribes it. So, it is popular, and patients also tend to overdose, once you write a prescription, the patients tend to take the drug on their own, and don’t come back to the doctors."

Deanxit enjoys a Rs 35 crore annual market in India itself. But what is disturbing, given those serious side-effects is that India is one of the few countries to even allow its usage.

Deanxit is banned for use in the country of it’s origin, Denmark. The US FDA, Drug Authorities in UK , Canada, Australia or Japan , have not approved this drug either. For such a drug, no clinical trials were carried out in India.

Taking note of these points, the Health Ministry has NOW setup a panel of medical experts to probe the side effects of this drug. But the bigger question is, who is responsible for the health of those patients who took this medicine for all this while?

Drug Expert, Editor MIMS Dr CM Gulati said “Why on Earth did the DCGI approve it? What were they thinking? Plus it is highly immoral and unethical on the drug company's part to sell a drug in India, which is banned in it’s country of origin! So, two major violations took place here.”

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Clinical trial reporting guidelines made stricter

The Drug Controller General of India has made it mandatory for pharma companies and clinical research organisation in the country to submit information on serious adverse reactions during clinical trials within 14 days of occurrence in a standardised format.

The drug controller has asked the drug firms to clearly mention whether a specific adverse effect is related to the clinical trials, whether it has resulted in fatality of the volunteer and whether compensation for the injury or death has been provided. This comes in the backdrop of the civil societies and drug experts raising concerns on the laxity in implementation of protocols by pharma firms, CROs in clinical trials across the country.

While the law already provides for reporting of such incidents through schedule Y of Drug and Cosmetic Act, it is the strict implementation of the Act that DCGI is aiming at. The drug regulator also made it compulsory.

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New Guidelines by DCGI for Clinical Trials

Clinical trials are an indispensable part of medical R&D to test the safety and efficacy of a new drug, treatment or a diagnostic technique in humans. While these are essential in the fight for better health, India has been shockingly lax in enforcing strict guidelines, and indeed even in evolving a stringent protocol for the same. Serious questions were raised about rules and regulations related to clinical trials when four girls died in Andhra Pradesh last year, after being administered a vaccine for human papiloma virus to prevent cervical cancer. While a committee has concluded that the deaths were most likely unrelated to the vaccine, it nonetheless put into sharp focus the existing protocol and safeguards for volunteers.

The Drug Controller General of India (DCGI) has finally come out with new draft guidelines that make it mandatory for all companies conducting critical trials to take the written consent of the volunteer. This provision has been arbitrary until now, leading to allegations that “informed consent” is a fallacy since volunteers are seldom given a full picture of the trial or of the risks involved. The socio-economic status of the volunteer too has to be mentioned: this could set the alarm bells ringing if there’s any widespread exploitation of any particular section of society. Equally importantly, the guidelines require the companies to report to the DCGI any serious adverse effect during the conduct of the trial, the reasons for that and details of compensation given.

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Sparsha Pharma to launch 3 transdermal products soon, got DCGI nod for marketing one

Sparsha Pharma International, the lone manufacturer of transdermal patches, a medicated adhesive patch that is placed on the skin to deliver a specific amount of drug through skin and into the bloodstream, is planning to launch three products in a couple of months.

The Hyderabad-based company already has a product, fentanyl transdermal patch, in the market. Fentanyl is a potent synthetic narcotic analgesic with a rapid onset and short duration of action. It was given to Dr Reddy’s Laboratories with exclusive rights for one year to sell in the domestic market in 2009 and Dr Reddy’s is marketing the product under the brand name, Finrid. Later, after the expiry of the exclusivity period Sparsha launched the product in the domestic market last year under the brand name, Fen-Touch.

“We are planning to launch two more products in a couple of months and we have already received approval from the Drugs Controller General of India (DCGI) for one of the products. Both the products are for pain management. Another product, which is for the treatment of asthma, is in clinical trial stage and will launch in a few months”, Dange Veerapaneni, managing director, Sparsha Pharma International, told Pharmabiz.

The company has a technology collaboration agreement with Japan-based leading transdermal patches manufacturer. Sparsha, with a manufacturing capacity of 1.5 crore transdermal patches per annum, is planning to invest Rs.60 crore in two phases as a part of expansion of its existing facility near Hyderabad. Sparsha is also mulling options to engage in contract manufacturing services

Commenting on the advantages of transdermal delivery, Dange Veerapaneni said that it avoids stomach upset common to orally administered drugs, side effects are less as the drug does not travel to all parts of the body and the drug is not subject to degradation during the first-pass effect as compared many oral drugs.

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