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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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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DCGI asks state drug controllers to immediately cancel licenses for Artemisinin

The Drugs Controller General of India (DCGI) has asked the state drug controllers to immediately cancel the manufacturing licenses of oral single drug formulations of Artemisinin and its derivatives, and also to ensure that no consignment of oral single drugs fonnulations of Artemisinin and its derivatives is exported from India with immediate effect.

The DCGI's order comes in the wake of WHO reports that continued use of Artemisinin derivatives as monotherapy for the deadly disease malaria is one of the main factors which contributes to the development and spread of drug resistance.

The WHO had some time back written to the DCGI stating that there is increasing evidence that the continued use of the Artemisinin derivatives as monotherapy is one of the main factors which contributes to the development and spread of resistance. Resistance to Artestinate was first reported in 2009 in limited geographical area at the Thai-Cambodian border, where Artemisinin have been used alone as monotherapies for many years, especially in the private sector.

Artemisinin based combination therapy is-the first line of treatment for all P. Falciparum malaria cases around the world. Monotherapy with the Artemisinin has been withdrawn in India also.

Earlier, the question of phasing out of oral single drug formulations of Artemisinin and its derivatives from the market was considered in the 39th meeting of the Drugs Consultative Committee held on December 10, 2008 at the DCGI office.  The committee after deliberations agreed that oral single drug formulations of Artemisinin derivatives like Artesunate and Artemether should be withdrawn from the market in a phased manner by July 2009.

However, it has been brought to the notice of the DCGI office that some of the manufacturers are exporting the monotherapies of Artemisinin to other countries, which prompted him to act tough in this regard.

Monotherapy with Artemisinin poses a great threat to global malaria control as resistance in any part of the world can be detrimental to the use of Artemisinin-based Combination Therapy in other parts of the world, the DCGI in its order said.

Alarmed over the emerging situation in this regard, the WHO had recently warned that 'the world risks losing its most potent treatment for malaria unless steps are quickly taken to prevent the development and spread of drug resistant parasites'.

The global plan for artemisinin resistance containment outlines the necessary actions to contain and prevent resistance to artemisinins, which are the critical component of Artemisinin-based Combination Therapies (ACTs), the most potent weapon in treating falciparum malaria, the deadliest form of the disease. Resistance to artemisinins has already emerged in areas on the Cambodia-Thailand border. Although ACTs are currently more than 90% efficacious around the world, quick action is essential. If these treatments fail, many countries will have nothing to fall back on, the WHO warns.

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Stiff rules in offing for clinical research organizations

The noose is all set to tighten against organizations which conduct clinical trials for pharmaceutical companies. 

The Drug Controller General of India (DCGI) is all set to make it mandatory for all clinical research organizations (CROs) in India to register with it so that their activities can be closely monitored and their scientific credentials checked. The draft rules were published on January 19. A copy of the rules is available with the TOI.

What is interesting is the requirement for CROs to maintain all records for a period of five years after the final results are submitted, so that these can be scrutinized any time. New rules say, "All records such as protocols, approvals from the Central Drugs Standard Control Organization and ethics committee, audit certificates, completed and final reports, shall be maintained. All documentation and communication are to be dated and preserved safely for five years after completion of the study or submission of the data to CDSCO."

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DCGI to ask Centre to increase drug inspectors under CDSCO to 500

The office of Central Drugs Standard Control Organisation (CDSCO) may ask the Centre to increase the number of drug inspectors under it to 500 as the requirement of the regulatory staff will be much more with its increased responsibilities, according to Dr Surinder Singh, DCGI.

He was addressing IPA president’s national seminar on ‘Regulatory challenges-global pharmaceutical market’, organised by the Indian Pharmaceutical Association (IPA), in Hyderabad recently. The DCGI said that manpower is being increased substantially. There were only 12 drug inspectors with the Central Drugs Standard Control Organisation in 2008. Currently the CDSCO has 72 drug inspectors and the government has agreed to increase to it 150. 

The DCGI is also in the process of creating state-of-the-art infrastructure across the country. The CDSCO, which already has its network in 9 states, is planning to expand its network into three more states. The DCGI is planning to delegate the power to approve drugs to zonal and sub-zonal centres. The authority to renew the licenses of blood banks will also be delegated to zonal and sub-zonal centres.

He said that in order to check the menace of spurious drugs, 2-D barcodes and Unique Identification (UID) will have to be introduced on the labels. “Consumers can know by SMS whether the drug is genuine or not. It is not going to be very expensive and it will cost only 35 paise. It will empower the consumers.”

Commenting on the inspections of overseas manufacturing facilities, DCGI said that the first team will go to China within 15 to 20 days. In the future, teams will be dispatched not only to China but to Italy, other European countries and US as is the case with US FDA and Medicines and Healthcare Products Regulatory Agency (MHRA) of UK.

Dismissing the reports that Indians are becoming guinea pigs in the clinical trials being carried out by multinational companies in India, he said that India hosts only 1.5 per cent of the trials are carried out across the globe. Countries such as the US and Canada have the highest number of trials and that’s why they are able to come up with new drugs, he said.

R P Meena IPS, director general, Drugs and Copy Rights, Andhra Pradesh Drug Control Administration asked the industry to find a solution for the huge fee required for registration of drugs in overseas countries as it’s a major problem for the small and medium companies. He urged the government to delegate powers to state drug controllers to issue licenses and regulate clinical trials.

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DCGI sends notices to NIMS, Apollo for allegedly conducting clinical trials on Arogyashree patients

The Drugs Controller General of India (DCGI) has sent notices to two major Hyderabad-based hospitals - Nizam's Institute of Medical Sciences (NIMS) and Apollo Hospitals - seeking clarifications for allegedly conducting clinical trials without proper permission from the authorities.

The DCGI notice to these prominent hospitals in the country is based on a news reports in a prominent daily which said that Arogyashree patients are being turned to guinea pigs in these hospitals and also stated that clinical trials are being conducted at these hospitals.

The DCGI asked the companies to explain on the news report which alleged that Nizam's Institute of Medical Sciences, Hyderabad and Apollo Hospitals, Hyderabad are making enormous economic gains by conducting clinical trials on poor patients. The news column also states that the most of the clinical trials are taking place in government hospitals because recruitment of patients is easy and getting a signature on the consent form is not difficult. The drugs which are being tested there are for diabetes, cancer, cardiac, gastro and liver conditions. Certain drugs for hormonal problems as well as rheumatic disorders are also being tested there. The news report further states that manpower is being hired to carry out the trials to meet its growing demand.

“In view of above you are requested to furnish the clarification in respect of the following issues: The number of clinical trials being undertaken by your organisation along with number of subjects involved and other details of such trials; Whether the requisite permission for conducting such clinical trials has been obtained from the per cent DCG(I); and whether the trials being conducted are registered at Clinical Trial Registry of India (www.ctri.nic.in)”, the DCGI letter said.

The DCGI has asked the two companies to provide details by February 18 this year.

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