State drug control officials not empowered to monitor clinical trials

State drug control officials not empowered to monitor clinical trials: Dr Jagashetty

June 12, 2012, 0800 IST – Source : Pharmabiz News

State drugs control departments have no powers to keep tabs on the clinical trials conducted in their states unless they are empowered as per the Drugs & Cosmetics Act & Rules, according to Dr BR Jagashetty, drugs controller, government of Karnataka.

The department’s team of inspectors has no authority to enter the premises of the clinical trial organizations, said Dr Jagashetty following the recent statement by the Drugs Controller General of India (DCGI), Dr G N Singh who said that the state DCs were required to keep a close vigil on the illegal human studies.

Without empowerment under the D&C Act & Rules, there is no question of inspection and even the clinical trial companies will not permit the inspectorate teams to enter the premises for the inspection, he added.

Further state drugs control departments have no information on clinical trial or clinical research organizations. There is also no mention of human studies in the D&C Act. So far no state drugs control departments have been involved in conducting inspections on clinical trial companies.

A key focus of a clinical trial is to assess the safety of the drug and efficacy. There has been several initiatives to look at pharmacovigilance, a adverse drug monitoring activity, from the government side. “There is definitely need for an audit and a dedicated team of inspectors to be in place to carry out the inspections of all clinical trials,” said Karnataka drugs regulator, said Dr Jagashetty.

India has around 40 clinical research organizations (CROs) including domestic and multinational companies. Out of these, there are around 20 leading companies and Karnataka is home to at least 15 of these CROs. The notable names are Ecron Acunova, Clinigene which is part of Biocon Limited, Lotus Labs. Omnicare, Vaatsalya, Treista Life Sciences which is part of Health Care Global Enterprises (HCG), St. John’s Medical College Clinical Trial Centre, Synchron, D2L, SMO India and Infinitus which are the homegrown companies.

In addition the state also has a presence of global majors include Quintiles, PharmaNet, PharmaOlam and ClinTech International to name a few. Besides this, there are corporate and government hospitals engaged in clinical trials. These cover Manipal Hospital, Fortis, Columbia Asia, Ramaiah Memorial Hospital where international pharma majors identify a principal clinical investigator to carry out the human studies.

CROs annoyed over continued delay in giving approvals for clinical trials by DCGI

CROs annoyed over continued delay in giving approvals for clinical trials by DCGI
November 11, 2011, 0800 IST – Source : Pharmabiz News

The clinical trial industry in the country is annoyed over the continued delay in giving approvals for the clinical trials, including the bioavailability and bioequivalance (BA/BE) studies, by the office of the Drug Controller General of India (DCGI).

Industry sources said that ever since the controversy surrounding the Hyderabad-based CRO Axis Clinicals hit the headlines, the DCGI office has virtually stopped giving clearance to clinical trials including the BA/BE studies and ordered auditing of all the Clinical Research Organisations (CROs) in the country to ensure that these studies are performed strictly in accordance with the applicable regulatory provisions and prescribed guidelines in the country.

Admitting that the clinical studies should be done strictly in accordance with the prescribed guidelines in the country, industry sources however said that the inordinate delay in getting approval from the DCGI office is adversely affecting the clinical trial sector as a whole in the country as the business is gradually shifting to other countries where decision making is fast and prompt.

They said that at a time when there is intense competition in the field, the non-clearance of these studies by the Indian regulators will adversely affect the Indian CROs. Due to its several factors including cheap labour and skilled workforce, India is becoming a hotspot for clinical research activities in the world. But this kind of attitude by the Indian regulators will act against the overall interest of the CROs in the country, they said.

The regulators started tightening the regulations on the clinical trial sector in the country after the controversy in June this year surrounding the Hyderabad-based CRO, Axis Clinicals, in which the company is alleged to have conducted clinical trials of a breast cancer drug on nearly 30 illiterate agriculture labourers after luring them with Rs.10,000 each. The incident created such a hue and cry in the country over the illegal activities of the CROs that the DCGI ordered auditing of all the CROs in the country.

His decision was prompted by the findings in the investigations on Axis Clinicals which revealed that there were various irregularities in conduct of BA/BE studies with respect to subject recruitment process, informed consent process, independence of the Ethics Committee and its review and decision making process.

CROs in AP form forum to build awareness and create transparency in clinical trials

Source : Pharmabiz News – September 09, 2011, 0800 IST

To bring transparency and promote good practices among the Clinical Research Organizations (CROs), some clinical research organizations have formed a forum in Andhra Pradesh. This forum has decided to maintain video and audio recordings of volunteers of trials, but loopholes and contradictions still exist in the process.

“We have formed a forum called the AP Clinical Research Organization (APCRO); initially it is a group of five out of 12 CROs in the state. Our main focus is to build awareness about clinical research industry and promote good practices amongst our members. It will also work closely with the Drug Controller General of India (DCGI) for better adherence of rules and address transparency issues and will maintain video and audio recordings of volunteers,” said R. Sirish Kumar, CEO, CRBio.

The five organizations that have come together to the form the forum are QPS Bioserve India, Sipra Labs, Azis Clinicals, Aizant Drug Research solutions and CRBio. Video and audio recordings of the consent process at the time of enrolling volunteers will be made to rule out any deficiencies and complaints of inadequate briefing of volunteers.

“In the case of illiterate volunteers from rural and tribal areas, the bioequivalence process will be explained to a legal heir or a blood relative, who is literate enough to understand it,” said Sirish.

Clinical trials are undertaken by pharma companies, and CROs are concerned with the bioequivalence (BE) studies, which is administering a single dose of the existing generic drug to healthy people and is safer than clinical trials, which is done on patients. Today the BE study is a $100 million industry in India. However, trials need to be conducted in the local, ethnic population to evaluate the efficacy of drugs.

Dr V Satyanarayana, managing director of Sipra Labs, said, “A common volunteer data base will be compiled to prevent cross participation. The DCGI will conduct annual inspections and monitor it at regular intervals.”

 

Mushrooming of CROs much be brought under check: Dr Mohandas

August 09, 2011, 0800 IST – Source : Pharmabiz News

Keeping in view of the dangers to the lives of the masses, measures have to be strictly initiated to control the mushrooming of Clinical Research Organisations (CROs) in the country as most of the upcoming institutions are not following the ethical norms, according to Dr K Mohandas, vice-chancellor, Kerala University of Health Sciences (KUHS).

While inaugurating a national seminar on “effective intervention of pharmacovigilance in the Indian scenario” at Al Shifa College of Pharmacy in Malappuram in Kerala, Dr Mohandas said stringent norms are required to monitor the new CROs and the authorities must have a watchful eye over their functioning to sensitively assess whether they follow the ethical norms. He said multinational companies from abroad are looking at India as the hub of clinical trials, so pharmacovigilance has to be strengthened in our rural as well as urban areas.

He exhorted the CROs and the professionals participating in the studies to conduct the trials by strictly adhering to ethical values. According to the VC, the volunteers who are subjected for the study should be educated about the laws related to it.

Addressing a scientific session on “patient medication safety and pharmacovigilance’ that followed, Dr S Sriram, HoD, Department of Pharmacy Practice, College of Pharmacy, Coimbatore said it is high time India’s pharmacovigilance programme to be strengthened and the pharmacists of the country can play the major role towards that end. He opined that pharmacovigilance could easily identify the risk factors in the shortest time so that the harmful effects could be avoided or minimized.

Regarding patient safety, he said, it refers to the evaluation of medication errors that occur at the stages of prescribing, dispensing and administering drugs. It strives to educate clinicians and patients about the correct use of a particular drug. Drug safety and medication safety are subsets of patient safety. Medication safety is a strategy of medication administration which ensures “five rights,” that is, right patient, right medication, right dose, right route and right time, pointed out Dr Sriram.

In the seminar, Dr Surulivel Rajan from Manipal College of Pharmacy spoke on “pharmacovigilance in clinical trial and clinical practice.”

Managing Trustee of Al Shifa College, P Unneen presided over the function. Dr R Saraswathy, director of the College, Dr P Yahia, Principal, Dr K Mohammed Haneefa, vice-principal and Dr S Durgaramani, HoD, department of pharmacy practice spoke on various subjects.

More than 160 pharmacy students from various colleges participated in the national seminar and awards were given to the best poster and oral presenters.

 

DCGI embarks on auditing of CROs to ensure BA/BE studies are conducted as per norms

DCGI embarks on auditing of CROs to ensure BA/BE studies are conducted as per norms –  July 15, 2011, 0800 IST  – Source : Pharmabiz News

To ensure that the bio-availability and bio-equivalence (BA/BE) studies are performed strictly in accordance with the applicable regulatory provisions and prescribed guidelines in the country, the Drugs Controller General of India (DCGI) has started auditing of all the clinical research organisations (CROs) in the country. According to sources, the DCGI office has already completed auditing of CROs in Andhra Pradesh and Mumbai. Now, the CDSCO panel will start auditing of CROs in other states also. Earlier, the DCGI had formed panels for auditing of CROs which included assistant drug controllers and drug inspectors. The DCGI’s decision to go in for a thorough auditing of all the CROs in the country comes in the wake of the recent controversy surrounding the Hyderabad-based CRO, Axis Clinicals, in which the company is alleged to have conducted clinical trials of a breast cancer drug on nearly 30 illiterate agriculture labourers after luring them with Rs 10,000 each. Though the company claimed that it had permission from the Central Drug Control Authority to conduct clinical trials, there were public criticism that the trials were being carried out in flagrant violations of rules, and instead of rats and guinea pigs, the company was using poor women for the studies. The DCGI immediately ordered an investigation into the allegation of certain irregularities in conduct of clinical study by M/s Axis Clinicals Ltd, in violation of the norms specified in Schedule Y of the Drugs and Cosmetics Rules. The investigations have revealed various irregularities in conduct of the above said studies with respect to subject recruitment process, informed consent process, independence of the Ethics Committee and its review and decision making process. The investigations were conducted on 20th and 21st June 2011 at the Bio-equivalence study centre of the company situated at Serlingampally, Miyapur, Hyderabad. Subsequently, the DCGI suspended the approval for conducting all BA/BE studies at their centres in Miyapur, Hyderabad, in public interest. The DCGI further decided to investigate the working of all BA/BE study centres in the country to avoid the recurrence of such incidents in the country.