M.Sc in Pharmacology at AIIMS

M.Sc in Pharmacology at All India Institute of Medical Sciences (AIIMS)

Duration: 2 years
Date of Entrance Examination: July 11, 2009 (Saturday, in Delhi only)
No. of Seats: 4

Eligibiliy: Candidate must possess a degree of M.B.B.s/B.D.S and have secured atleast 55% marks (50% SC/ST candidates) or B.V.Sc or B.Pharma or B.Sc degree course (3 years) with atleast 60% marks (55 % SC/ST candidates)

Last date of for receipt of applications: April 21, 2009

click here for more info

Colleges offering Pharm.D in Maharashtra and Madhya Pradesh

Madhya Pradesh
Shri Ramnath Singh Instt. of Pharmaceutical Sciences & Technology
Intake: 30


Maharashtra
Bharti Vidyapeeth University, Poona College of Pharmacy
Intake: 30

Colleges offering Pharm.D in Karnataka

Following are the colleges that offer Pharm.D in Karnataka.

The intake in each of these colleges is 30.

1. M.S. Ramaiah College of Pharmacy
2. Navodaya Education Trust's N.E.T. Pharmacy College
3. Hyderabad Karnataka Education Society’s, College of Pharmacy
4. Sri Jagadguru Mallikarjuna Murugharajendra College of Pharmacy
5. B.V.V. Sangha’s Hanagal Shri Kumareshwar College of Pharmacy

Colleges offering Pharm.D in Tamilnadu

Following are the colleges that offer Pharm.D in Tamilnadu, each with an intake of 30 students.

1. VEL’s College of Pharmacy, Chennai
2. S.R.M. College of Pharmacy, Chennai
3. PSG College of Pharmacy, Coimbatore
4. Vinayaka Missions's College of Pharmacy, Salem

Colleges offering Pharm.D in Andhra Pradesh

Following are the colleges offering Pharm.D in Andhra Pradesh.

No. of seats in each college is 30.

1. Smt. Sarojini Ramulamma College of Pharmacy
2. Raghavendra Institute of Pharmaceutical Education & Research (RIPER)
3. Deccan School of Pharmacy
4. Talla Padmavathi College of Pharmacy
5. Bharat Institute of Technology
6. St. Peter’s Institute of Pharmaceutical Sciences
7. Sri Venkateshwara College of Pharmacy
8. GIET School of Pharmacy
9. Malla Reddy College of Pharmacy
10. Shri Vishnu College of Pharmacy
11. Vaagdevi College of Pharmacy
12. P. Rami Reddy Memorial College of Pharmacy

Pharm.D in India

Pharm.D. Course is currently being offered in five states in India.

• Andhra Pradesh
• Karnataka
• Madhya Pradesh
• Maharastra
• Tamilnadu

Senior Drug Inspector of Pondicherry Suspended

A senior Drug Inspector working with additional powers of the State Licensing Authority in the Union Territory of Pondicherry was placed under suspension for allegedly misbehaving with higher officials in the department. Sources from the department said M Dhanasekaran has been suspended as per Central Government Employees Conduct Rules, for his misdemeanour in the office. P Rajkumar, a staff in the public health laboratory has been handed over the power of state licensing authority. A news article in Pharmabiz stated.

CDSCO begins Audit of Clinical Trials

Central Drugs Standard Control Organisation (CDSCO) while awaiting to make sure that all CROs get registered from June this year has already launched audits of ongoing clinical trials by the expert teams comprised of drug inspector, pharmacologist and clinical trials experts.

This kind of audit held for the first time by CDSCO has identified glaring deficiencies with several sponsors, CROs and Monitors.

With more strict regulations being implemented along with such onsite audits, regulatory bodies can now ensure that the safety and rights of the trial subjects are well protected.

Hope the subjects volunteer to participate in trials and are not subjected to clinical trials.

More drug inspectors for Andhra Pradesh

It is learnt that the Andhra Pradesh drug control administration is currently in the process of appointing more Drug Inspectors. The number of inspectors who will be added new to the system is 105 which will increase the strength of Drug Inspectors to 159.

The number of Drug Inspectors to be appointed new is almost double the current strength. More personnel in the system could hopefully be a path towards a much efficient drug regulatory system in Andhra Pradesh!!

Rimonabant to be banned in India ?

Drug Technical Advisory Board has recommended a ban on the use of anti-obesity drug, 'Rimonabant', in the country for the possible side effects it can cause.

Studies showed that it had serious psychiatric side effects including the suicidal tendencies. The drug, a potential blockbuster, was launched in Europe in 2006, but faced similar predicament in the developed countries.

Sanofi-aventis had already stopped the sales of the anti-obesity drug called Acomplia throughout Europe, in view of concerns that the medicine entailed more risks than benefits for those taking it. The French company had also announced that it would not take the same drug to other countries also. In 2007, the United States Food and Drug Administration (FDA) had banned the anti-obesity drug based on manufacturer's studies that revealed Acomplia increased the risk of the patient developing depression, anxiety and stress disorders.The European Medicines Agency, after its study, has also revealed that overweight or obese people who had been treated with Acomplia were at a double the risk of suffering from psychiatric problems than a group of patients who had been given a placebo instead for their condition.

Guidance for Industry on Submission of Clinical Trial Application for Evaluating Safety and Efficacy

Guidance for Industry on Submission of Clinical Trial Application for Evaluating Safety and Efficacy

This Guidance has been developed in conformity with Drugs and Cosmetics and Rules there under and GCP Guidelines of India for the purpose of submission of Clinical Trial application.

This guidance was available at the CDSCO website and can be downloaded from here

Training programs in Clinical Trials

National Institute of Pharmaceutical Education and Research (NIPER) is conducting training programs in clinical trials.

Statistics in Clinical Trials - 14 – 18 April 2009
Protocol writing - 24 – 28 August 2009
Statistics in Clinical Trials - 26 – 30 October 2009

click here for more details.

Institutes offering clinical research course

Found three new Insititutes that offer clinical research course.

International Center for Training in Clinical Research( ICTCR)	http://www.ictcr.org/
Sharda Group of Institutions	http://www.sgei.org/HICR.htm
Institute Of Computational Biology	http://www.iocbindia.org/

The number of institutions increase like anything and I wonder if there exists any regulatory body governing such institutes (when the DCGI office is still struggling to enforce strict regulations on the conduct of clinical trials, I think it is too early for me to anticipate the functioning of any body to regulate institutions offering clinical research course. The PCI is still struggling to get all the regulatory rights from AICTE.. hope that happens soon and the regulation of Pharmacy education in India becomes much more streamlined.)

PCI to enter agreement with AACP of US for faculty exchange programme

A recent release in Pharmabiz stated that Pharmacy Council of India (PCI) will soon enter into an agreement with Association of American College of Pharmacy (AACP) under which the pharmacy colleges in US and India can exchange their faculties. AACP is an association of several pharmacy colleges in the US.

The faculty exchange programme with US is significant in the wake of the widespread opinion among the experts in the pharmacy education in the country that the existing faculty in the country is not well versed to teach a course like Pharm D which was introduced in the country last year by the union health ministry. Though a total of 27 pharmacy colleges have received approval from the PCI last year to start Pharm D, it is understood that many of them did not start this advanced course so far, mainly due to the lack of good faculty.

The tie-up with the AACP is part of the PCI's efforts to rope in experienced faculties from other countries where Pharm D programme has been existing for some time.

FDA Takes New Regulatory Action Against Ranbaxy’s Paonta Sahib Plant in India

The U.S. Food and Drug Administration recently announced that a facility owned by India-based Ranbaxy Laboratories falsified data and test results in approved and pending drug applications. The facility, Paonta Sahib, has been under an FDA Import Alert since September 2008.

The FDA is continuing to investigate this matter to ensure the safety and efficacy of marketed drugs associated with Ranbaxy’s Paonta Sahib site. To date, the FDA has no evidence that these drugs do not meet their quality specifications and has not identified any health risks associated with currently marketed Ranbaxy products.

In the meantime, the FDA recommends that patients not disrupt their drug therapy because this could jeopardize their health. Individuals who are concerned about their medications should talk with their health care professional.

The affected applications are for drugs that fall into three categories:

• Approved drugs made at the Paonta Sahib site for the U.S. market;
• Drugs pending approval at the FDA that are not yet marketed; and
• Certain drugs manufactured in the United States that relied on data from the Paonta Sahib facility.

“Companies must provide truthful and accurate information in their marketing applications,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The American public expects and deserves no less.”

To address the falsified data, the FDA has invoked its Application Integrity Policy (AIP) against the Paonta Sahib facility. The AIP is invoked when a company’s actions raise significant questions about the integrity of data in drug applications. This AIP covers applications that rely on data generated by the Paonta Sahib facility only.

Under the AIP, the FDA has asked Ranbaxy to cooperate with the agency to resolve the questions of data integrity and reliability. This would include implementing a Corrective Action Operating Plan (CAOP) to provide assurance of the integrity and reliability of data from the Paonta Sahib facility. A CAOP includes, but is not limited to, conducting a third-party independent audit of applications associated with Paonta Sahib.

When the AIP is implemented, the FDA stops all substantive scientific review of any new or pending drug approval applications that contain data generated by the Paonta Sahib facility.

“The FDA’s investigations revealed a pattern of questionable data raising significant questions regarding the reliability of certain applications, and this warrants applying the Application Integrity Policy,” said Deborah Autor, director of CDER’s Office of Compliance. “Today’s action reflects the FDA’s continued vigilance and its steadfast commitment to safeguarding the public’s health.”

On Sept. 16, 2008, the FDA issued two warning letters and instituted an Import Alert barring the entry of all finished drug products and active pharmaceutical ingredients from Ranbaxy’s Dewas, Paonta Sahib and Batamandi Unit facilities due to violations of U.S. current Good Manufacturing Practices requirements. That action barred the commercial importation of 30 different generic drugs into the United States and remains in effect.

Read the FDA’s 2008 Warning Letters to Ranbaxy and the Import Alert

Read the redacted AIP letter to Ranbaxy

As the Ranbaxy shares continue to fall, it is learnt that Daiichi and Ranbaxy have already formed a team to solve the issue.