About the Partnership for Safe Medicines India
The Partnership for Safe Medicines India is a group of organizations and individuals that have policies, procedures, or programs to protect consumers from spurious or contraband medicines. For more information, please visit www.safemedicinesindia.in
PSM LOGO 17th July
News Archive
Editor's Emulsion

Pooja Khaitan


A combination drug most commonly refers to a fixed-dose combination (FDC), which is a formulation including two or more active pharmaceutical ingredients (APIs) combined in a single dosage form, which is manufactured and distributed in certain respective fixed doses.

Initially, fixed-dose combination drug products were developed to target a single disease (such as with antiretroviral FDCs used against AIDS). However, FDCs may also target multiple diseases/conditions, such as Caduet or EXFORGE. (Caduet contains atorvastatin to treat hypercholesterolemia and amlodipine to treat hypertension.)
Our government has finally got cracking on regulating harmful and irrational combination medicines in the market, directing pharma manufacturers to prove their safety and efficacy claims.


If you have any suggesstions , comments or queries, please email me at pooja@safemedicinesindia.in .
You may find our previous issues on our website www.safemedicinesindia.in or in the NEWS ARCHIVE section of every PSM NEWZ issue , in case you’ve missed any of them. You may also look us up on Facebook .

Best wishes ,

Pooja Khaitan
Editor-In-Chief ,
Partnership for Safe Medicines India.

PSM India @ United Kingdom
Pathways to safe medicines: protecting patients through unified global action

Wednesday 26-Friday 28 June 2013, Wilton Park, Steyning,
West Sussex BN44 3DZ, United Kingdom

It was a life-time experience for me. At an extremely beautiful location surrounded by nature inside a Heritage Building called Wilton House, we discussed on unsafe medicines in the supply chain and how it is undermining patient safety.

Dose of the day
Upcoming Events

National Training Workshop on “Secured Medicines & Robust Pharmacovigilance - Key to Patient Safety & Health” Organised By Government of India and State Governments Managed By Partnership for Safe Medicines (PSM) India Initiative on 23rd August at Bangalore and 26th August 2013 at Mumbai

World Drug Safety Conference
When: September 10-12, 2013
Where: London, UK
Description: Click here>>>

Partnership for Safe Medicines Interchange
When: October 24, 2013
Where: Washington, DC
Description: Click here>>>

National Injections
2 drugs found spurious in Jammu and Kashmir
SRINAGAR,2013: The Drug Controller General of India (DCGI) today confirmed that two drug samples taken from Jammu and Kashmir hospitals for testing efficacy have been found spurious. “The Union of India (UoI) filed a status report on behalf of DCGI saying that we have received efficacy report of 25 out of 156 drug samples taken from different places in Jammu and Kashmir. Out of the 25 samples two have been found spurious,” Showkat Ahmad Makroo, the Assistant Solicitor General of India told this reporter.
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Government cracks down on harmful Fixed Dose Combination drugs
MUMBAI, JULY 2013: The government has finally got cracking on regulating harmful and irrational combination medicines in the market, directing pharma manufacturers to prove their safety and efficacy claims. This comes close on the heels of a recent move banning three widely used medicines, including diabetes drug pioglitazone. Such combination medicines, also called fixed dose combinations (FDCs), are popular across several therapeutic areas like painkillers, antibiotics, cough remedies and anti-depressants.
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Drug Law and Policy Injections
Schedule H1 antibiotics to be limited to only 48 instead of 91 proposed earlier

NEW DELHI, JULY 2013: The Government will include only 48 antibiotics in the proposed Schedule H1, instead of 91 antibiotics as planned in the original proposal. The notification to include this as a separate new Schedule aimed at monitoring and regulating the sale of antibiotics in the country is expected soon. According to the new proposal, cleared by the Drugs Technical Advisory Board (DTAB), the Schedule H1 will have only third, fourth generation and carbapenum class of antibiotics.

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Health ministry to set up expert panel for banning plastic bottles in pharma packaging

MUMBAI, JULY 2013: The union health ministry will soon constitute an expert committee for examination and generation of scientific opinion on the issue of banning of packaging of pharmaceutical products in Polyethylene Terephthalate (PET) bottles and plastic bottles due to public health and environmental hazard. The issue of banning of PET and plastic bottles for packaging of pharmaceutical products was taken up by the Drugs Technical Advisory Board (DTAB) in its meeting held on May 16 this year.

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Government mulling ban on sale of TB drugs in open market

NEW DELHI,JULY 2013: Sale of tuberculosis drugs could be prohibited in open market as part of efforts to ensure calibrated and monitored administration of these medicines which would then only be given on daily basis free of cost by government registered outlets to patients. The Health Ministry is proposing changes in view of irregularity in administration of these drugs to patients and lack of proper monitoring which is hindering efforts to check the disease, sources told PTI.

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Global Injections
Spain police seize illegal Chinese medicine

MADRZID, JULY, 2013: Spanish police said today they had seized hundreds of thousands of packets of unlicensed medicine illegally imported from China , including erection aids and slimming products. The Civil Guard "seized more than 250,000 units of illegal medicine, mostly related to erectile dysfunction, slimming and abortion practices," it said in a statement.

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US FDA Cracks Down on Illegal Pharmacy Websites

MARYLAND, 2013: The U.S. Food and Drug Administration and international regulators shut down 1,677 illegal online pharmacy websites this week, and seized more than $41 million worth of illegal medicine worldwide, according to a statement by the FDA. The authorities seized the offending websites, and posted messages on them warning visitors about the websites' alleged illegal activities, and the potential harms of buying counterfeit drugs.

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Nigerian texters to take on fake drugs

"With the crackdown on illegal narcotics, drug barons have redirected their resources to manufacturing counterfeit medical products because it is more lucrative and less risky," says Dr Paul Orhii, the director general of Nafdac. Comprehensive surveys have not been carried out for some years, but a report by the World Health Organization in 2011 suggested the war is far from won. It said more than two-thirds of malaria medicine in Nigeria was fake or substandard.

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Pharma Injections
Government to review suspension of 3 drugs

NEW DELHI, JULY 2013: The Drug Technical Advisory Board (DTAB), the government’s top advisory body on medicines, is likely to meet on July 19 to review the recent suspension of manufacturing and selling of three widely prescribed medicines – anti-diabetes Pioglitazone, painkiller Analgin and anti-depressant Deanxit – in India. The industry, which has strongly opposed the suspension, is also expected to make a representation in the meeting, producing scientific as well as clinical data in support of the suspended medicines.

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Global Injections

“Human rights aren’t just about violence and terrorism. Unsafe drugs too fall into the category. The National Human Rights Commission (NHRC) has described the manufacture, distribution and sale of unsafe drugs and medical devices as a violation of human rights.”

We welcome your valuable contributions and news articles . Please feel free to write to THE EDITOR-IN-CHIEF at
pooja@safemedicinesindia.in regarding the same . We shall be delighted to include your articles in our next issue .

"Call PSM India toll free helpline 1800 - 11- 4424, to bring cases of spurious medicines or any kind of adverse drug reaction to the notice of the authorities.
Please visit our website www.safemedicinesindia.in if you wish to learn about us .
To register a complaint kindly visit our consumer redressal website www.consumerconexion.org

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Disclaimer : Our newsletter endeavors to compile patient safety information from various sources .PSM India may not be held responsible for any article published in PSM NEWZ .