Thursday, July 30, 2015

India: the pharmacy of the world where 'crazy drug combinations'

India has been called the pharmacy of the world. Many generic drugs are made there and much of its drug production is exported internationally. Thousands of fixed dose combination drugs – where two or more drugs are combined in a set ratio in a single dose form, usually a tablet or capsule – are formulated, made and sold within India.

Many FDCs are safe and effective. They are used in situations where both the drug combination and the doses needed are standardised and stable, for example, in the treatment of HIV, for Parkinson’s disease and in contraceptive pills.

However, in a study investigating these drugs in India, we found thousands of FDCs on the market made up of formulations never approved for marketing by the national regulator, the Central Drugs Standard Control Organisation, and that were likely to be more harmful than beneficial to patients.

As two pharmacologists in India, writing in response to our study put it:
One can find any crazy drug combination which could give nightmares to any doctor who has some understanding of the concept of the rational use of medicine. It is simply beyond comprehension of any rationalist. Even antimicrobials are being combined weirdly, which is a grave challenge for crusaders against antimicrobial resistance.

FDCs in India

Considered an innovation of India’s national pharmaceutical industry, FDCs are promoted extensively and used in huge numbers within the country. These drugs are mostly available through wholesalers, pharmacies (not necessarily with a prescription), dispensing doctors, but some are used in hospitals too.

For years though, there has been disquiet. In 2007, the national regulator banned 294 of the drugs because they had never been approved for marketing but had been given manufacturing licenses by authorities. FDC manufacturers disputed the ban and the matter remains unresolved in the courts. In 2012, an Indian government committee investigating the standards and capacity of the regulator issued a report highlighting multiple problems, including FDC approvals.

The committee found state authorities were issuing manufacturing licenses for new formulations that were never approved. It said: “The end result is that many FDCs in the market have not been tested for efficacy and safety. This can put patients at risk”. Many formulations were also medically unnecessary.

The report noted that “ambiguities” in the rules on new drugs prior to an amendment to existing legislation in May 2002 might have encouraged the marketing of FDCs without approval. However, we identified no ambiguities in the drug rules and found that just as many unapproved new FDCs appeared on the market after the amendment as before.

The scale of the issue

The committee’s report included no investigation of the size of the problem or potential risks to patients, so we used drug approval records (1961-2013) and commercial sales data (2007-2012) to identify approved and unapproved FDCs on the market and calculate the quantities being sold.

We examined four areas: pain-relief, diabetes, anxiety/depression, and psychosis. We chose these because the drugs are commonly used and many, even when used alone, have serious side effects.

In the four areas, we found 175 FDC formulations on the market, 115 (66%) with no record of approval. Metformin drugs for diabetes had the best approval compliance, anti-psychotics the worst.

FDC formulations give rise to many branded products made by different pharmaceutical companies, each promoting their own products in a crowded marketplace. Among anti-inflammatories, there were almost 3,000 branded products, with more than 1,000 of them made from unapproved formulations. Vast volumes of these FDC products are sold in India.

Banned or restricted in other countries

Among the products on the market, we found numerous combinations containing drugs that are banned or restricted in other countries. Some of these were formulations actually approved by the regulator, others were unapproved. They included, for example, melitracen, an antidepressant widely banned owing to central nervous system toxicity (in India its top-selling combination with flupentixol, an anti-psychotic, was banned in 2013, re-approved, then banned again in 2014, and nimesulide, an analgesic also widely banned due to its association with liver toxicity and put under sales restrictions in 2007 by the European Medicines Agency.

Several anti-inflammatories included a muscle relaxant drug banned because of damage to dividing cells in the body while yet others contained two types of anti-inflammatory together, giving no advantage for pain but increasing the risk of serious side effects including bleeding in the stomach and heart attack.

Some combinations were potentially lethal, for example, an anti-psychotic containing two drugs from the same class, both individually associated with major toxicity including sudden death. Dozens of antidepressant and benzodiazepines included combinations of sedating drugs shown individually to increase the risk of falls and accidents.

Response and remedy

Following the committee report in 2012, the Indian government made attempts to improve FDC regulation. But there was little enforcement. In fact, manufacturers lobbied against regulatory change, making “an earnest appeal” to government to “maintain status quo”, both approved and unapproved, marketed up to September 2012. And that is exactly what has happened.

It is clear from our research that drug regulation in India, a key international exporter of medicines, needs a major overhaul. Unapproved FDCs should be banned and patients transferred to appropriate single drugs. Public health, not manufacturers’ commercial concerns, should inform the regulation of India’s drugs.

But all too often, as we have found, business comes first and citizens are the losers. Alongside Indian medical and legal colleagues, we are now working to see unapproved FDCs banned once and for all and to draft a new drugs act for India. With strong and clear legislation, a most important step will be taken to ensure that in the long term the people of India have safe and effective drugs made in their country.

http://scroll.in/article/742599/india-the-pharmacy-of-the-world-where-crazy-drug-combinations-go-unregulated

Sainsbury’s has sold its 281-store pharmacy business to Celesio

Sainsbury’s has sold its 281-store pharmacy business to Celesio, the owner of the Lloyds Pharmacy chain, for £125m.

Under the deal, Lloyds will rent out and run Sainsbury’s 277 in-store pharmacies and take over four located in hospitals. Up to 2,500 Sainsbury’s pharmacy staff will transfer to Lloyds.

Mike Coupe, chief executive of Sainsbury’s, said: “Working together with a specialist operator like Lloyds Pharmacy will enable us to grow and extend our pharmacy services to customers, whilst realising value for shareholders today from the pharmacy business we have grown organically over the last 20 years.”

Analysts said the cash from the deal would further strengthen Sainsbury’s balance sheet after the retailer raised £500m through bond issues last week. It told analysts that roughly half the bond funds would be used to pay down its pension deficit while the other half would be used to “get on the front foot with corporate plans”.

Bruno Monteyne, an analyst at Bernstein Research, said: “These funds are not immediately necessary. The market was not waiting for this, but it is reassuring if somewhat unexpected.”

Without major pressure from investors for cash-raising measures, Sainsbury’s sudden flurry of fundraising activity is likely to heighten speculation that the retailer is looking to buy out a chain or batch of stores to help expand either its convenience store brand, Sainsbury’s Local, or its nascent discounter joint venture, Netto.

Sainsbury’s plans to reach a total of 15 Netto stores this year, including the buy-out of three Co-op stores in Leeds, Hull and Doncaster, which is currently being reviewed by the competition regulator.

http://www.theguardian.com/business/2015/jul/29/sainsburys-sells-pharmacy-business-celesio-125m

Sunday, July 12, 2015

French startup 1001Pharmacies just raised $8.9 million (€8 million) from Newfund, CM-CIC Capital

French startup 1001Pharmacies just raised $8.9 million (€8 million) from Newfund, CM-CIC Capital PrivĂ©, and business angels, such as Xaviel Niel, Pierre Kosciusko-Morizet and Olivier Mathiot. As the name suggests, 1001Pharmacies is an online pharmacy.

The company first let you order your prescription goods from their website. In order to avoid legal issues, 1001Pharmacies partnered with hundreds of brick-and-mortar pharmacies and acted as the middleman, handling deliveries, payments and listings.

Last August, the company had to stop its prescription delivery service as a French court ruled that delivering prescription goods was illegal. That’s why the company refocused on non-prescription goods, from toothpaste to vitamin C effervescent powder. As long as you don’t need a prescription, you can find it on 1001Pharmacies.

And it looks like this strategy is working as the company managed to raise €8 million despite last year’s ban. 1001Pharmacies still hopes that it will be able to sell prescription goods in the near future.

As this is a highly regulated industry, 1001Pharmacies faces challenges that it wouldn’t face in other countries. But if the startup can crack the code in France, it will create a significant barrier to entry for other potential competitors.

Finally, the marketplace approach is interesting. Not having to manage a huge inventory and many of the less-scalable tasks of an e-commerce startup is a great asset. Clients can even order stuff online and then grab them at their local pharmacy. It’s a great way to know for sure that the pharmacy will have what you are looking.

Pharmacies get a new sales channel, 1001Pharmacies takes a cut, and clients have another way to buy non-prescription goods. As these goods have very high margins, 1001Pharmacies may have found a lucrative business.

techcrunch.com/2015/07/09/1001pharmacies-grabs-8-9-million-to-bring-your-pharmacy-to-the-web/

PGI will come up with its own pharmacy

PGIMER officials are working towards setting up its own pharmacy, which will provide minimum 50 per cent discount (or more) on all drugs to its patients. The final report has been approved by the PGI director and the location to set up the pharmacy has been decided.

The renovation work has started and the authorities claim that in the next seven-eight months, the PGI will come up with its own pharmacy. The purpose would be to cater to poor patients coming to PGI who are at times ‘overcharged’ by private chemists, officials said.

Earlier, on June 15, the final report about the PGI’s own pharmacy was approved by the institute’s Director and the pharmacy committee. The report was prepared by the six-member committee after studying the best pharmacy models of other hospitals.

“Now, we are working on the Standard Operating Protocol, which will be presented to the Standing Finance Committee for clearance. The meeting will be held in August,” said Dr Arvind Rajwanshi, head, cytology department. He is also heading the six-member committee involved in the project.

The institute would demand nearly Rs 50 crore from the Health Ministry for execution of the project.

“The amount will be refundable. We are positive about getting our proposal and funds sanctioned from the health ministry. Once approved, we will start the execution work,” Dr Rajwanshi added.

To begin with, the PGI is going to start one pharmacy, which will be in the place of current pharmacy in the Nehru building. “We have already directed that the current pharmacy be vacated as we have to start the renovation. Currently, it caters to only staff, but the new pharmacy will serve all PGI patients. It will have eight counters opened for different categories like indoor, outdoor patients and others,” Dr Rajwanshi said.

Further, in the standard operating protocols other issues like staff recruitment, legal formalities, storage facilities, cold-room, method of procuring medicines, administration charges and other details will be decided.

Unlike the old pharmacy, the new one will not come under the Medical Superintendent. It will be chaired by an independent professor in-charge and will be following all financial rules.

“PGI will directly contact the manufacturing companies for procuring drugs. We will procure medicines at high discount from companies and will sell it further to patients. Patients will be given medicines at minimum 50% of discount. It can be more than 50% but not less. Nothing will be free,” said Dr Rajwanshi.

Talking about another facility, Dr Rajwanshi said, “We are planning to increase the hospital admission fees by Rs 100-150 per day and in return we will supply to patients basic things such as cotton, gauge, needles, bandage, IV fluids in every ward.”

He said that these items are most commonly used in wards for indoor patients, and every now and then attendants have to run to the chemist shop.

http://indianexpress.com/article/cities/chandigarh/pgi-pharmacy-plan-gets-push/99/