FMRAI passes resolution against DCGI's recent decision to ban 4 drugs

The Federation of Medical and Sales Representatives Associations of India (FMRAI) has passed a resolution against Drugs Control General of India’s recent decision to ban certain drugs produced and marketed in the country. The Federation passed the resolution in this regard in its general council meeting that held in Kota in Rajasthan last week.

According to FMRAI, the DCGI is deliberately creating ground for MNCs to capture markets for certain segments of drugs which have been in use and in circulation for several years in India.

Recently, the Union health ministry has banned four drugs based on the recommendations by Drugs Technical Advisory Board. The unsafe drugs are nimesulide, cisapride, phenylpropanolamine (PPA) and placentrex. FMRAI office-bearers said these drugs have been banned by the ministry without making a proper scientific study on each of the drug.

While quoting placentrex as an example, the office-bearers said it has been manufactured and marketed in India by the Kolkota based company Albert David for more than fifty years. The medicine was available in the form of lotion, gel, and injection and being actively promoted as a remedy for a variety of unrelated disorders such as vitiligo, wound dressing, prevention of adverse effects due to radiotherapy, fallopian tube blockage, female infertility, scarring, post-phlebitic ulcers, scars due to acne, etc. For conducting surgery, orthopaedic treatments and in gynaecology also this medicine was being used widely.

One medical representative of Albert David said he is marketing this medicine in Tamil Nadu for several years and so far no doctor has suspected its safety and no adverse effect has been reported. He said the company, which has a turnover of 70-80 crores, has got more than 350 medical representatives and it employs about 750 people in various capacities. The ban of placentrex will make these employees and representatives jobless, he believes.

The resolution of FMRAI says comprehensive and scientific studies should be conducted to ban the use of any drug. It alleges that the present ban on four drugs is because of pressure from vested interests which will adversely affects the nation’s economy and the pharma industry.

No more BCG Vaccine production from Government Manufacturing units

The government seems to have no plan to produce vaccines from its own vaccine manufacturing units namely BCG Vaccine Laboratory in Chennai, Pasteur Institute of India, Coonoor and Central Research Institute at Kasauli. It has decided to procure almost all the vaccines required for the country’s national immunization programme from the private vaccine companies with no check on their quoted prices. The companies like Serum Institute of Pune, Bharat Biotech, Green Signal Biopharma, etc. are some of the main suppliers of vaccines to the national programme now. It is more than three years after the Union health ministry headed by Dr Anbumani Ramadoss ordered the closure of three public sector vaccine manufacturing units. After the closure of the vaccine units there has been a steady rise in the prices of most of the widely used vaccines in the country. With this, the expenditure on universal immunization programme had also increased substantially. The health ministry after the closure of the vaccine units had claimed that it could negotiate with the private players and manage to procure vaccines at lower prices. But, a scrutiny of prices of vaccines procured by the government from the private players clearly shows that the rates for the year of 2009-10 were much higher than the rates in the previous years. In fact the private players used to offer the vaccines at competitive prices before the closure of the PSU units as per the information available from the health ministry itself.

The Parliamentary standing committee on health and family welfare, headed by Amar Singh, had taken serious objection to the continuing delay on the part of the health ministry in resuming operations of the three closed PSU units. The committee felt that the suspension of manufacturing licences of the three units should be revoked at the earliest and they should restart their production. Considering the prices at which vaccines are offered by the private players, the government should not have allowed any delay in this matter.

The government cannot afford to ignore a suggestion like this from a Parliamentary panel. But, the health ministry did not bother to undertake the modernization of the vaccine units during last three years even when shortages of vaccines were being reported by state governments. At a time when multinational drug companies are taking over the pharmaceutical industry of the country, the Central government has a critical role to play in supplying at least some of the essential drugs and vaccines to the poorer sections of the society. As it is, there is a steady rise in the prices of most of the widely prescribed medicines as majority of the drugs are outside the price control.

CDSCO team to begin overseas inspections with Chinese sites from March

The much-awaited inspection of overseas sites by the team from the Central Drugs Standard Organisation (CDSCO) is expected to finally begin in March with the office of the Drugs Controller General of India identifying 10 sites in China in the first phase.

The DCGI office has finalised the list of manufacturing sites and the drug inspectors to be sent for auditing and inspection and the process will begin sometime in March itself, sources said. China has been selected as the first stop for the inspection in the wake of increasing complaints against the quality of drugs and APIs being imported from there.

In the second phase, the inspections will most likely to cover Italy as first country in Europe, with the view to ensure quality of products coming to India, sources added, without revealing the identified sites in China. The necessary training for the short-listed drug inspectors has already been given in accordance with the international standards. Further course of action will be taken by the authorities based on the report of the visiting drug inspectors, sources added.

The DCGI had some time back banned the import of raw materials from 10 Chinese drug companies as they did not comply with the mandatory regulatory standards here. It is not known whether the manufacturing sites of these companies were also included in the list prepared now for inspections.

The proposal for overseas inspections has been gathering momentum for quite a long time as there was strong call by the domestic industry to the authorities and make it part of the import registration policy, as followed by many other developed nations. Countries like United States have their own representative offices in India and other places to conduct these kinds of audits regularly.

More drugs to be banned in India

DCGI office has informed about the possble ban of Tegaserod and Gatifloxacin in two weeks of time. This has come soon after the recommendation from DTAB to ban Nimesulide, Cisapride and products containing placental extract.

1st Convention of Women Pharmacists

Indian Pharmaceutical Association (IPA)-Education Division, Peenya branch in association with Acharya & B M Reddy College of Pharmacy is organising the first convention of women pharmacists 2011 (power and purpose) on March 8, 2011 at Acharya college campus, Bangalore.

The programme is being organised to create awareness about the Women Pharmacist League and the beginning of empowering women pharmacists in India. At present women constitute an important section in the pharmaceutical sector and a large number of women pharmacists are well qualified and struggling in their care.

In pharmacy about 50 per cent of the women power is present. They are more adaptable to all the sectors and are most preferable in pharmaceutical care, legal care and chemical pharma care. So PCI has granted the permission to start the league in India as every country is having a women league including US, UK, Australia, the organisers of the programme said.

They also added that they will soon start their own website to increase awareness about empowering women in pharmaceutical sector and also going to start an interaction on networking websites.

Their role is to participate actively in the research areas of pharmacy division and for the realisation of women’s equality and development in all spheres of life and also help those in enriching their awareness in job spectra and higher education. A training programme will also be arranged to share their experience as pharmacists.

Dr B Suresh, president, Pharmacy Council of India (PCI), Prof T V Narayana, chairman, IPA-Education Division, Dr Divakar Goli, Secretary, IPA Education Division, who is also the professor & principal of the Acharya & BM Reddy College of Pharmacy will be present during the programme which will start under the supervision of Prof. Kalyani Divakar, treasurer, Acharya & BM Reddy College of Pharmacy and Prof. Kalyani Prakasam, secretary, Acharya & BM Reddy College of Pharmacy.

Workshop on “Phase I trials: Regulations, operations & management”

25-26 February 2011

at Hotel Green Park, Hyderabad

By

Arkus Clinical Trial Support Solutions, Ahmedabad &

PharMantra Consulting Services, Hyderabad

Trainers - Dr. Anupama Ramkumar M.D

Ranjani Nellore, Ph.D., RAC

Cost of the program: Rs. 9500/

(Inclusive of course material, lunch and refreshments)

Who would benefit – Considering the current interest and thrust on Phase I trials in India, this interactive workshop will be invaluable to all companies interested in getting into the fast-expanding business of Phase I trials. All clinical research professionals involved in the planning, outsourcing, conduct or oversight of Phase I trials will benefit by enhancing their knowledge of Phase I trials and the specific expertise required for the successful conduct of these studies.

About the trainers:

Dr Anupama Ramkumar, M.D (Med) is a well known GCP Trainer in India and runs Arkus Clinical Trial Support Solutions, a rapidly growing, training and consulting firm engaged in assisting sponsor companies running their trials in India, helping identify/audit CROs/sites and other vendors for optimal trial conduct and logistics. She has been a part of the clinical research Industry in India since its early days and has herself been an Investigator on Phase 1 trials while working as the Medical Director at Lambda Therapeutic Research, Ahmedabad,India.

Ranjani Nellore, Ph.D. RAC is a regulatory affairs certified professional with over 12 years of pharmaceutical industry experience in USA and India. She has submitted clinical trial applications and INDs to FDA, MHRA, TPD (Canada) and DCGI for several NCEs. She has participated in meetings with the EMEA and US FDA. She is an invited speaker at national and international meetings and renders customized training programs. She has now established PharMantra Consulting Services which provides regulatory consulting services to the global health science industry.

To register, please send email to:Anupama@arkusresearch.com; ranjani@pharmantra.com or

Call - Dr Anupama at 98254 13761 or Dr. Ranjani at 99590 72225