Scheme could remove roughly 4.4m devices currently incinerated or sent to landfill

Pharmaceuticals giant Teva launched the State’s first inhaler recycling project in a move that could deal with the roughly 4.4 million devices that are often incinerated or sent to landfill.

Teva, which supplies medicines to deal with asthma, has established a pilot scheme to encourage the estimated 560,000 people in the Republic living with a respiratory-related illness to recycle their inhalers.

While people that use inhalers are encouraged to return their used devices to pharmacies, those devices are then incinerated. Inhalers that aren’t brought to pharmacies often end up in landfill.

Under Teva’s scheme, available across 100 pharmacies, the used inhalers can be returned to certain pharmacies where they’ll then be recycled and used to make products such as playground materials and garden equipment.

Two inhalers
“Many people living with respiratory-related illnesses typically have at least two inhalers at any one time – a reliever and a preventer – which amounts to a large volume of plastic waste. However, this initiative provides them with the opportunity to contribute to a greener Ireland, ” said Sarah O’Connor, chief executive of the Asthma Society of Ireland.

The company has partnered with TerraCycle, a global recycling group, which has created a box to collect and store the inhalers until they’re taken away for recycling.

“We’re excited to launch this pilot with the Asthma Society of Ireland, and we hope that with their support, with buy-in from our pharmacy partners and people living with respiratory-related illnesses, this pilot program can make a difference,” added Teva’sspeciality medicines director ClodaghKevans.

Source: irishtimes

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This is the fourth mass glycol poisoning event in India that has been caused due to a pharmaceutical drug. In 1973, there was a similar incident at the Children’s Hospital, Egmore in Chennai that caused the deaths of 14 children. In 1986, similar poisoning at Mumbai’s J.J. Hospital caused the deaths of 14 patients who were otherwise on the path to recovery. In 1998, 33 children died in two hospitals located in New Delhi due to similar poisoning. In all three cases, the manufacturer of the suspect cough syrup, due to negligence or human error, failed to detect and contain the level of diethylene glycol in the syrup, thereby causing poisoning of the patients who consumed it.

Tracking the sold bottles
There will be plenty of time later to ascertain the cause and prosecute the guilty but the immediate concern for doctors, pharmacists and the drug regulators should be to prevent any more deaths. The only way to do so is to account for each and every bottle of the poisoned syrup that has ever been sold in the Indian market and stop patients from consuming this drug any further. Any patient who has consumed even a spoon of the syrup should then immediately b referred to a hospital for treatment.

According to the information available on the website of the United States Food and Drug Administration (USFDA), in 1937, when the United States faced a similar situation with glycol poisoning, its entire field force of 239 inspectors and chemists were assigned to the task of tracking down every single bottle of the drug. Even if a patient claimed to have thrown out the bottle, the investigators scoured the street until they found the discarded bottle. This effort was accompanied by a publicity blitz over radio and television.

We do not see such public health measures being undertaken here; authorities are simply not communicating the seriousness of the issue to the general public. At most, the authorities in Himachal Pradesh (H.P.), who are responsible for oversight of the manufacturer of this syrup, have made general statements that they have ordered the withdrawal of the drug from all the other States where it was marketed. However, there is no transparency in the recall process and information about recalls and batch numbers is not being communicated through authoritative channels. There is no public announcement by the Drug Controller General of India (DCGI), which is responsible for overall regulation of the entire Indian market. The suspect product, although manufactured in H.P., has been sold across the country. The website of the DCGI, which is supposed to communicate drug alerts and product recalls, has no mention of Coldbest-PC as being dangerous as of this writing.

Need for a recall policy
One of the key reasons why the DCGI and state drug authorities have been so sloppy is because unlike other countries, India has not notified any binding guidelines or rules on recalling dangerous drugs from the market. The 59th report of the Parliamentary Standing Committee on Health as well as the World Health Organization (in its national regulatory assessment) had warned the DCGI on the lack of a national recall framework in India. A set of recall guidelines was drafted in 2012 but never notified into law. In 2016, in a report submitted by me to the Ministry of Health suggesting measures to reform the drug regulatory framework, I had pointed out to the Ministry that a national drug recall framework was in urgent need. In a pending case before the Delhi High Court, I have also sought for the notification of a national recall mechanism. The government is yet to file its response.

While a national recall of this adulterated medicine is the immediate need, the administration also needs to quickly identify which other pharmaceutical companies have received the spurious ingredient that was supplied to the manufacturer in H.P. from a trader in Chennai. It is very likely that the trader in question marketed the same ingredient to other pharmaceutical companies, who, like the manufacturer at the centre of the present scandal, may have failed to test it for its identity and purity. It is important for regulatory enforcement to raid and seize the records of the trader in Chennai and verify its sales. As of today, we have little to no information on whether any of this is happening. The lackadaisical response of drug regulators in India is not surprising. It is the result of a larger lethargy and arrogance that is emblematic of the babudom which is responsible for keeping us safe from unethical practices of pharmaceutical companies.

Source: thehindu

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Laurus Labs, one of the world’s largest producer of anti-HIV and hepatitis-C bulk drugs, is striving to become a vertically integrated drug manufacturer, as it tries to win supply tenders in high competitive global tenders for antiretrovirals (ARVs) and gain toehold in US generics market.

The company is moving both downstream into formulations to improve margins, and upstream into intermediates to cut dependence on China, and ensure reliability of supplies.

Laurus is already seeing the change. The bulk drugs or active pharmaceutical ingredients that constituted about more than two-thirds of revenues for the Hyderabad-based company, have now dropped to 40 percent.

Laurus, which has been moving up the value chain into formulations, has invested around Rs 750-800 crore on developing products and building factories to meet the most stringent of regulatory expectations.

The drug maker has the capacity to produce 8 billion tablets, and is well-positioned to operate at peak capacity by June-end as it anticipates higher demand.

The company has so far filed 24 abbreviated new drug applications (ANDAs) with US FDA. It has five final approvals, three tentative approvals and two have completed validations.

Laurus filed for ARV products and have approvals for DLT (Dolutegravir, Lamivudine, Tenofovir), DTG (Dolutegravir)/TDF (Tenofovirdisoproxilfumarate), and ET (Emtricitabine/Tenofovir DF).

Laurus won tenders awarded by Global Fund, US President’s Emergency Plan for AIDS Relief (PEPFAR) and country-specific, driving this business from Rs 5.1 crore in 1QFY19 to Rs 300 crore in 3QFY20.

In an exclusive interview to Moneycontrol, SatyanarayanaChava, CEO of Laurus Labs, said the company will be chasing products where it has competitive edge like having vertical integration,scale, and ability to manage supply chain better.

Chava said he believes that there is enough room for Laurus to grow in the highly competitive market anti-HIV drugs market.

“The funding for HIV, malaria, tuberculosis prevention and treatment is around $20 billion, the spend on anti-HIV drugs wouldn’t be more than $2 billion, there isn’t much room to cut. Adding to the many emerging countries like South Africa, China, India and Thailand are funding their procurement,” Chava said.

Reducing Chinese dependence
With raw materials from China forming the backbone for the anti-HIV APIs, Laurus starting further backward integration by manufacturing intermediates.

The shortages and steep price hikes of Chinese raw materials in 2018 made Laurus to develop in house capabilities to manufacture intermediates, which it was depending on China until then.

“We are backward integrated to intermediates to counter regulatory and pricing challenges,” Chava said.

Nowadays regulators are inspecting the intermediate facilities. Chava says that the compliant ones have increased prices.

“The economies of scale that they have achieved on anti-HIV products have helped them to start manufacturing intermediates,” Chava said.

But Chava said that bringing down complete dependence on China for raw materials isn’t possible.

“At maximum we can reduce our dependence of up to 50 percent, even this can only be achieved for products where we have huge volumes,” Chava said.

Source: moneycontrol

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