OTC sale of around 92 antibiotic and anti-TB drugs will be clamped down in India soon

Resistance to antibiotics is becoming a serious threat to Indians because of popular habit to pop pills at will which is an irrational use.  A recent study by the Centre for Disease Dynamics, Economics and Policy, said there has been a six-fold increase in the number of antibiotics being popped by Indians.

In order to avoid such irrational use, DCGI has written to the Union health minister to notify a new schedule H1 in the Drugs and Cosmetics Rules. Once notified and following the clearance from the law ministry, these drugs cannot be sold without prescription. These drugs will also have to carry a prominent label in red colour with the following warning: "It is dangerous to take this prescription except in accordance with medical advice and not to be sold by retail without the prescription of the registered medical practitioner."

This is a very welcome news as we and world, staring at a post-antibiotic era, when common infections will no longer have a cure.

Source : Media reports

Pollution-related issues are haunting few AP Pharma units

While the Visakhapatnam district administration has sought the closure of the Mylan unit along with four other units in the pharma city operated by Ramky, the Andhra Pradesh Pollution Control Board (APPCB) has issued closure notices to 12 units around Hyderabad.


It is believed that villagers near Ramky’s Vizag pharma city have been complaining that the units there pollute air, affecting their health. In response, the district administration swung into action to verify the veracity of their allegations. According to sources, the APPCB, acting on the district administration’s request, conducted a study and confirmed air pollution. This led to immediate closure notices for five units (belonging to Mylan, Vegesna Laboratories, Actus Pharma, Vijay Organics and Acacia Life Sciences, respectively).

The Andhra Pradesh Pollution Control Board (APPCB) has issued closure notices to 12 bulk drug units located in Hyderabad while directing their managements to stop all the industrial activities by July 23, 2012. Of the 12 bulk drug manufacturing units currently under the PCB axe, two units belong to Aurobindo Pharma while four units are of Hetero Drugs Limited.

The units involving other companies are Crix Pharmaceuticals, Covalent Laboratories, Divis Pharmaceuticals, Krishna Pharmaceuticals, Innogent Laboratories and SMS Pharma Limited.

In a press release, the board said that these units were asked to close down under the Water & Air Acts in the interest of protecting public health and environment. “After detailed discussions, the board is of the firm opinion that certain industries are violating the orders of the Supreme Court of India and the ban notification issued by the Andhra Pradesh government, among others,” the press release said.

 
( source:   news  papers and  press releases)

Another Block buster bites the dust

Yet another milestone on pharma's journey away from the mega blockbuster era: Plavix (the world's second-best-selling medicine) goes off patent. And unlike Pfizer BMS plans to back off Plavix marketing immediately. Thanks to the monopoly Plavix enjoyed, USD 9 Billion on its peak and it brought in $6.6 billion in net U.S. sales last year and the drug has generated an estimated $42.8 billion for the company during its 15 years on the market.

FDA said it gave seven companies permission to sell generic Plavix or clopidogrel in the standard 75-milligram dose. According to the FDA, 75-milligram generic Plavix can now be sold by Apotex Corp., Aurobindo Pharma, Mylan Pharmaceuticals, Roxanne Laboratories, Sun Pharma, Teva Pharmaceuticals and Torrent Pharmaceuticals.

The larger dose of 300 mg will be sold by Dr. Reddy's Laboratories, Gate Pharmaceuticals, Mylan and Teva.