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Pharmaceuticals Newsletter - September 03 to September 07, 2012

India Infoline News Service/ 17:41 , Sep 07, 2012

The Drug Controller General of India (DCGI) reportedly told pharma companies to submit the mandatory safety details of their new drugs for every six months for the first two years from their launch to ensure safety and efficiency when consumed by patients.

Top Stories 

CCI issues order against Chemist & Druggist Association, Baroda

The Competition Commission of India (CCI) has found Chemist & Druggist Association, Baroda (CDAB) in violation of the provisions of Competition Act, 2002 which deals with anticompetitive agreements. CCI had imposed a penalty of Rs. 53,837 @10% on the average of the income for financial years 2006-07, 2007-08, 2008-09 on CDAB which has to be paid by it within 90 days from the receipt of the order.

This case was initiated on a complaint dated 28.04.2009 filed by Shri Uday Joshi of Vedant Bio – Sciences, Baroda before the Monopolies & Restrictive Trade Practices Commission ( MRTPC”) against the Chemists & Druggists Association of Baroda (“CDAB”) .

The complaint had alleged the following anti competitive practices:-

(i) CDAB had formulated guidelines for its members which require approval or NOC from them for appointment as Stockist / Wholesalers of different companies.

(ii) CDAB was imposing unfair conditions in sale of pharmaceutical products of different companies.

(iii) CDAB forces the additional/new Stockist not to sell the products of a pharmaceutical company unless NOC is obtained from the existing Stockist of that pharmaceutical company in that area.

(iv) CDAB insists on procuring NOC before a pharmaceutical company launches new products or appoints new Stockist.

(v) CDAB is engaged in fixing margins for pharmaceutical companies.

(vi) NOC has to be procured for several aspects like launch of new company products, appointment of new Stockist or addition of Stockist.

(vii) CDAB charges Rs. 2000/- per product from all companies launching new product in the market. These charges are collected towards the advertisements in their magazine called ‘Chemists News’. Price structure of each product is controlled through this advertisement and without detailed pricestructure, the products are not allowed to be launched.

CCI has directed CDAB and its members to cease and desist from indulging in and following practices which have been found anticompetitive in violation of Section 3 of the Act. The CDAB has been further directed to file an undertaking that practices with respect to fixing of trade margins of pharma products, non-appointment of stockiest of wholesaler from amongst the non-members of the CDAB, requirement of NOC from CDAB for appointment of stockist of wholesaler and limit on number of stockiest of pharmaceutical companies have been done away within 90 days from the date of receipt of the order.

Infocus News

Drugmakers told to submit safety report on new drugs every 6 mths

The Drug Controller General of India (DCGI) reportedly told pharma companies to submit the mandatory safety details of their new drugs for every six months for the first two years from their launch to ensure safety and efficiency when consumed by patients.

GN Singh,the Drug Controller General of India (DCGI) was quoted as saying, "It has been observed that some of the manufacturers and importers are not adhering to the critical requirements in totality which has been viewed seriously by the office."

According to reports, DCGI would cancel drug licences if the companies fail to submit their safety files.  For new cases, drugmakers have to declare the safety reports within a month of the completion of the six-month period.

The drug companies also have to provide the global marketing status of the new drug, changes in the reference of safety information and update on the actions taken for safety reasons, reports stated.

DCGI faced several criticism in recent times for lapses in implementation of drug laws, and has taken steps to tighten regulation which eventually has resulted in a sharp drop in the number of new drugs and clinical trial approvals, reports added.


Domestic News

Pharma sector anticipates a hiring freeze: Naukri survey

The overall economic crunch has resulted in companies adopting a cautious approach in their hiring plans. A survey with recruiters from the Pharma sector revealed a drop in overall hiring sentiment.  51% recruiters are expecting to add new jobs in the second half of 2012 which is 16% lower than what was predicted by them in Jan-2012 survey. Similarly, in Jan-12 none of the recruiters had predicted a hiring freeze in 2012, while now 11% recruiters are saying that hiring will come to a halt in the next six months.

Also, when we asked recruiters on what increments were given out to employees in 2012 then 59% said that the range was within 10% to 15% and about 25% said that increments given out were less than 10%.  Talent crunch seems to be an important issue being faced by recruiters in the Pharma sector as 73% said that it is very difficult to find talent suitable for a job profile.
 
Sumeet Singh, Senior VP Marketing and Communications, Info Edge India said “Although the overall hiring activity in the Pharma sector has been moving at a steady pace in the first half of the year, recruiters are now preferring to adopt a cautious wait and watch mode in the coming quarters”.
 
A deeper analysis of the job scenario for the sector shows that about 33% jobs created in the Pharma sector in 2012 are from Mumbai, 12% from Hyderabad and 11% from Bengaluru. Most job openings in the sector are for jobseekers in the 3- 5 years experience levels.

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International News

India signs MoU with Tajikistan for co-operation in healthcare

The Ministry of Health and Family Welfare, Govt. of India and the Ministry of Health of the Republic of Tajikistan signed a MoU for cooperation in the field of health and medicine in New Delhi today. While Shri Ghulam Nabi Azad, Union Minister for HFW signed on behalf of India, Salimov Nusratullo signed on behalf of Tajikistan.

The salient features are:-

1. Prevention of Communicable Disease
2. Medical Education, Health Research and Hospital Management
3. Setting up of diagnostic centres in Tajikistan
4. Import of Drugs and Pharmaceuticals preparations
5. Training of Medical/Para medical professionals and sharing of India’s experience in setting up of rural health centres
6. Promotion of Health Tourism
7. Traditional Medicine

The MoU also envisages exchange of information and experts in the field of health and medicine, training in the mutually agreed identified areas, deputation of experts to attend International meetings held in each other’s country.

A Joint Working Group will be set up to further elaborate the details of cooperation and to oversee the implementation of this Agreement. The Working Group will meet at least once in a year, alternately in India and Tajikistan.

The Ministry of Health and Family Welfare, Govt. of India and the Ministry of Health, Govt. of Tajikistan shall be nodal agencies for the implementation of this Agreement.

It may be mentioned that India had no official level engagement with Tajikistan in the areas of health & medicine in the past. 

 



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