Tides in India pharma, by Levin Thomas

Tides in India pharma, by Levin Thomas

1. India bans polyethylene terephthalate (PET) bottles as primary packaging material in pharma industry.

According to the recent notification by the health ministry, no manufacturer shall use the polyethylene terephthalate (PET) or plastic containers in liquid oral formulations for primary packaging of drug formulations for paediatric use, geriatric use and for use in pregnant and women of reproductive age.
The pharma companies have been given a transition period of six months until May 2015, to switch to glass bottles which, though are more expensive but ensures higher stability and efficacy of liquid formulations. Earlier the packaging industries had expressed objections on this ban. The ban was introduced on the recommendation of India’s Drug Technical Advisory Board (DTAB) in October, on the basis that plastic packaging has an adverse effect on humans due to the presence of endocrine disruptors – chemicals that can interfere with the hormone system. With the ban, the pharmaceutical industry will now have to switch to glass bottles-which accordingly will be a costlier affair. As the alternative for PET is glass container, an estimated increase of 25-30% per bottle is expected.

2. Toll free number to report ADR’s

Now, consumers can call to directly report adverse reactions or their bad experiences from any medicine. The health ministry has launched a toll-free number where people can call and report the side-effects and problems faced by them along with details of the medicine, suspected to have caused the adverse reaction. The information received would be then screened and assessed by the Adverse Drug Reaction Monitoring Centres by using international parameters set by the World Health Organisation (WHO). Thereafter, the analyzed information would be forwarded to the national coordinating centre, which maintains a database for adverse drug reactions (ADRs). The government would also share this database with international agencies including WHO, which manages the Global Pharmacovigilance Database. The ministry also plans to make it mandatory for pharmacists, hospitals and other independent clinics to display the toll free number - 18001803024 - in public interest. The idea is to empower consumers to report adverse reactions on their own

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3. US drug patent expiries to benefit Indian pharma industry

Expiry of drug patents in the US is great news for the Indian pharmaceutical companies that have an opportunity to capitalise on the patent cliff and gain a greater share of the growing generics market. At present, India accounts for nearly 40 per cent of generic drugs, over-the-counter products and 10 per cent of finished dosages used in the US. During 2014-2016, about $92 billion worth of patented drugs are expected to go off-patent in the USA as compared to $65 billion during 2010-12.  Indian companies' share in the US generics market has grown rapidly on the back of aggressive Abbreviated New Drug Application (ANDA) filings, successful pursuit of Para-IV and capitalisation on patent expiries of blockbuster drugs. Under US laws, ANDA filed with a Para-IV certification states that the generic company which is the first-to-file a Para IV, gets "exclusive rights" to sell the generic version of a branded drug for 180 days, with only the patent holder as the other player in the market. Ranbaxy, Dr Reddy's and Lupin have been the most prolific filers for Para-IVs. Indian players with a robust product portfolio, filings and necessary manufacturing infrastructure are well placed to capitalise on this forthcoming opportunity. Indian companies have built a strong pipeline of products to be sold in the US. During 2013, Indian companies secured 39 per cent of total 400 ANDA approvals from the United States Food and Drug Administration. Gleevec, Provigil, Combivent, Prezista, Benicar, Crestor, Avodart, Copaxone etc. are some of the top pharmaceutical brands undergoing patent expiry in US in 2015 and 2016.

 

4. New drugs approved in India (October-November)

Sl. No	Drugs	Indications
1.	Rivastigmine transdermal patch. Each Transdermal patch contains 27mg Rivastigmine.	For the treatment of patients with severe dementia of the Alzheimer's type.
2.	Dabigatran Etexilate Mesilate hard gelatin capsule- 75/110/150mg.	1. Treatment of acute deep vein thrombosis (DVT) and /or pulmonary embolism (PE) and prevention of related death. 2.Prevention of recurrent deep vein thrombosis (DVT) and /or pulmonary embolism (PE) and  related death.
3.	Olanzapine Pamoate-Prolonged release powder for suspension for I.M injection.	For the treatment of schizophrenia.
4.	Canagliflozin Tablet 100/300mg.	Indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type-2 Diabetic Mellitus.