Monday 29 February 2016

India top source for illicit medicines reaching Swiss shores

 PHARMA CRUSADERS



Amid much hoopla over alleged black money stashed by Indians in Swiss banks, Switzerland has disclosed that India is the top source for illegally imported medicines confiscated by their customs department. As per the latest data released by the Swiss government, India accounted for 42 per cent of the confiscated medicinal product shipments in 2015. Two thirds of all seized shipments originated in Asian countries, including India.

Without identifying the seized products that originated from India, the Swiss government agency for therapeutic products, Swissmedic, said that erectile stimulants accounted for 51 per cent of the confiscated medicinal products.Major product categories that were confiscated also include sleeping tablets and tranquillisers (15 per cent), slimming preparations (13 per cent), medically important, prescription-only medicines (9 per cent), while others were 12 per cent.

Switzerland has widely been known as a safe haven for parking illicit wealth amassed by Indians, given the famed secrecy walls of Swiss banks. Amid growing pressure from various countries, including India, these secrecy walls have begun to crumble in recent years. Switzerland has been sharing information on suspected cases of black money with the Indian authorities whenever they have been given credible evidence to back such claims. Releasing the latest data on illicit trade in medicines, Swissmedic said that the Swiss customs authorities reported 1,134 cases of illegally imported medicinal products in 2015.

Swissmedic monitors illegal medicine imports in close cooperation with the customs authorities. As the authority responsible for overseeing the therapeutic products, Swissmedic analyses suspicious shipments confiscated by customs, determines their risk potential and initiates appropriate action where necessary. The agency also works with national and international authorities and institutions to fight illegal medicine trade. It further said that fewer slimming products were imported in 2015, while more medicines containing narcotics were confiscated. Potency products still account for around half the illegal imports. The confiscated products originated from as many as 62 countries. While India accounted for 42 per cent of confiscated products, other Asian countries (primarily Thailand, China, Singapore, Cambodia) accounted for 24 per cent.

Western Europe (such as UK, Germany, Portugal) was the source for 18 per cent of such products, Eastern Europe for 8 per cent, Central and South America for 4 per cent, while other regions accounted for 4 per cent. Swissmedic further said that potentially dangerous active substances that are either incorrectly declared or not declared at all represent a growing problem. It also warned that most of the medicinal products procured from dubious sources on the internet have major quality defects.

Source: Government of Swiss

Wednesday 24 February 2016

Openings for Senior Technical Associates (13 Posts) on Contractual Basis at Indian Pharmacopoeia Commission, Ghaziabad, Last Date 2nd March 2016



The Indian Pharmacopoeia Commission (IPC) is an Autonomous Body under Ministry of Health & Family Welfare, Govt. of India primarily with the objectives of regularly updating the Indian Pharmacopoeia by publishing new edition and its addenda, National Formulary of India and other related tasks such as preparing, certification and distribution of reference substances & functions as National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI). 

We are looking forward for qualified personnel to fill up 13 posts of Senior Technical Associates (for NCC) in PvPI on Contract basis having Master’s Degree in Pharmaceutical Sciences or M.B.B.S/ B.D.S/ Pharm. D or equivalent, with three years experience in relevant field out of which two years experience in Pharmacovigilance. Preference will be given to young, dynamic personnel having proficiency in Computer Applications. Consolidated emolument @ Rs. 30,000/- per month will be paid by IPC. 

The job description of the post is:

* Review and analysis of PSURs and follow up with stakeholders. 
* Benefit-risk evaluation of Medicinal Products available in Indian Market. 
* To supervise the assigned work and assist the senior officials. 
* Assisting in quality review and signal review of ICSRs. 
* To provide Vigiflow hands on training to the newly engaged personnel in PvPI. 
* Any other activities as assigned from time to time by competent authority. 
* Assisting the NCC for document control. 

Applications are invited from citizens of India on the application format which can be downloaded from the website: www.ipc.gov.in of the Commission together with the attested copies of supporting documents within 15 days from the date of advertisement. 

The competent authority reserves the right to increase or decrease the number of vacancies and rejection and/or all applications received without assigning any reason. Selected candidates shall be posted at NCC-PvPI, IPC, Ghaziabad.

Openings for Technical Associates (40 Posts) on Contractual Basis at Indian Pharmacopoeia Commission, Ghaziabad, Last Date 2nd March 2016




The Indian Pharmacopoeia Commission (IPC) is an Autonomous Body under Ministry of Health & Family Welfare, Govt. of India primarily with the objectives of regularly updating the Indian Pharmacopoeia by publishing new edition and its addenda, National Formulary of India and other related tasks such as preparing, certification and distribution of reference substances & functions as National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI).

We are looking forward for qualified personnel to fill up 40 posts of Technical Associates (for NCC & ADR Monitoring Centres) in PvPI on Contract basis having Master’s Degree in Pharmaceutical Sciences or M.B.B.S/ B.D.S/ Pharm. D or equivalent. Preference will be given to young, dynamic personnel having experience in Pharmacovigilance and proficiency in Computer Applications. Consolidated emolument @ Rs. 25,000/- per month will be paid by IPC. 

The job description of the post is:- 

* Collection of ADR Reports. 
* Follow up with the reporter/patient for Completeness as per SOPs. 
* Data Entry in VigiFlow. 
* Reporting to NCC-PvPI through VigiFlow with the source data (Original)attached each ADR case. 
* Training/Sensitization/Feedback to physicians through news letter circulated by the NCCPvPI.
* Other activities as assigned by competent authority from time to time. 

Applications are invited from citizens of India on the application format which can be downloaded from the website: www.ipc.gov.in of the Commission together with the attested copies of supporting documents within 15 days from the date of advertisement. 

The competent authority reserves the right to increase or decrease the number of vacancies and rejection and/or all applications received without assigning any reason. Selected candidates shall be posted in any of the AMCs under PvPI across the country/NCC-PvPI, IPC, Ghaziabad.




Saturday 6 February 2016

Bharat Biotech gets breakthrough in developing Zika vaccine

 PRASHANTH KUMAR KILLI


Vaccines manufacturer, Bharat Biotech, announced a breakthrough in developing the world’s first Zika vaccine. The Hyderabad-based company has submitted two vaccine candidates — one inactivated and one recombinant — to the Indian government.

The company maintain that pre-clinical studies will be concluded in the next five months, after which the process for regulatory approval will commence.

An inactivated vaccine is when the disease-causing microbe is killed, typically, using chemicals, heat, or radiation. Such a vaccine is more stable and safer than live vaccines. A recombinant vaccine is a vaccine produced through recombinant DNA technology. This involves inserting the DNA encoding an antigen (such as a bacterial surface protein) that stimulates an immune response.

Dr. Krishna Ella, Chairman and Managing Director of the company said that one the two candidates is in advanced stage of development and can be ready soon. “In the coming two weeks, we will be able to start animal tests in one of the two candidates. Since this is a pandemic situation, we are hoping that the Indian government will move quickly of giving requisite approvals for the trials,” said Dr Ella.  

Bharat Biotech has submitted necessary information to Indian Council of Medical Research (ICMR) four days ago. The company is now looking to seek Prime Minister Narendra Modi’s approval to expedite regulatory clearances. “When Ebola vaccine candidates were being discussed, the company had skipped phase 2 trials and went on to phase three with a small sample size. Given the urgency of the situation, something of that sort will be required,” he added. Currently, getting regulatory approvals takes for conducting clinical trials in India can take up to 6-8 months.



Bharat Biotech filed patents for both vaccine candidates in July 2015, Dr Ella informed. He said that since the company already worked on chikungunya, this was the next logical step. “At the time we started working on the Zika vaccine, there was not a market incentive or any demand for it- largely because the symptoms are mild. But we were already working in chukungunya and our hypothesis was that the same vector transmits this disease as well, so we thought we need to look at this aspect as well,”


Source: The Hindu