Danish pharmaceutical company Lundbeck that develops drugs for targeted brain diseases, including depression, schizophrenia, Alzheimer's disease, Parkinson's disease and migraine is exiting India as part of the company's global strategy.

The $2.7 billion Lundbeck, which is based out of Bengaluru, has a sales and marketing team of around 100 people in the country. Lundbeck had brought out its patented anti-depressant drug into India a few years ago.

"Lundbeck has decided to exit its operations in India, in line with our strategy. We will continue to serve the market in India per local regulatory requirements, however the medicines that we offer in India have suitable alternatives. Patients should speak to their doctors about these alternatives if needed," the company said in an email statement to ET.

The company specializes in developing treatments for brain diseases and has treated millions of people for more than 70 years as per their website.

Lundbeck is headquartered in Denmark and located in more than 50 countries around the world. It has production facilities in Denmark, France, and Italy, and research centers in Denmark and the US. The company has employees in more than 50 countries, and employs approximately 5,600 people across the value chain.

                  According to pharma industry experts, standard of the drugs is the only concern for the market.

                China recently exempted import tariffs (duties) for 28 drugs, including all cancer drugs.

India is the largest provider of generic drugs globally with the Indian generics accounting for 20 per cent of global exports in terms of volume, according to pharma industry experts. The country is more focused on quality of drugs and medicines. Government is also working in the same context and can be seen centering more on policy making. This is overall constructive for the healthcare sector of the country, said the experts. 

Current status of pharma industry

The current status of pharma industry in India is decent. However, there are ongoing changes in policy which can lead to confusion in business. "Government keeps on changing guidelines which may obscure manufacturers but it's a good sign also as we are moving towards better side of India. If we look at wider perspective, the world can be divided into three kinds of countries - highly regulated, semi-regulated and non-regulated. Every country has its own policy and way of dealing with the industry", said Sanjeev Gupta, Managing Director, Kusum Group of Companies. 

The Indian pharma industry gained prominence since 1970s but manufacturers were not bothered about standards that time. The scenario was diverse, anybody came up to establish plants and manufacture them. 48 years have passed now and currently the country is concentrating more on regulation of drugs.

Government policies and pharma industry

The standard of manufacturing facilities should always be retained. According to Mr. Gupta, there are many encounters which the pharma industry often faces. In this pursuit, there may be conciliations with standard of drugs. However, the government is now working more on standards.

"Pharmaceutical industry is not a commodity. We should be focused more on standard and quality of the product. This is what the government is doing now. Government is more engrossed on policy making. They are taking resilient decisions for the concern of pharma industry. There may be ifs and buts but government is looking forward to work on criterion more which is a good symbol", added Mr. Gupta.

"There are mammoth opportunities in India. India is a good exporter of generic business and we have also taken a big jump recently. There are many people in small towns and villages who are not getting proper medicines. Government is trying to disentangle the concerns of these locations", he further said.

Threats to pharma industry

According to pharma industry experts, standard of the drugs is the only concern for the market. There are no basic threats to pharma industry in India. 70 per cent of pharma market is generic, 9 per cent is oriented and rest 21 per cent is over-the-counter (OTC) which is acceptable.

India's healthcare budget is less. The country spends only a small part of GDP (Gross Domestic Product) on healthcare while in other countries 4-5 per cent of GDP is outlaid on healthcare. There are no threats as India is working systematically.

Future concerns of pharma industry

India should become part of PIC/S (Pharmaceutical Inspection Co-operation Scheme). The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use.

"All FDAs (Food and Drug Administration) are part of PIC/S which ensures that all manufacturing is part of the system as well. Small countries like Vietnam and Uzbekistan which don't even have 5 factories want to become part of PIC/S now. India is also not the part of this society. India is doing a generic business and we are contributing to around 20 per cent medicines of world. This means every fifth tablet created in India is used worldwide. In this scenario, it is important that we become part of the PIC/S. We are part of WHO (World Health Organization) reality but it is not essential for all the industry. PIC/S is more important for us. I am sure in future we will become part of the system", said Mr. Gupta.

China recently exempted import tariffs (duties) for 28 drugs, including all cancer drugs, from May 1, 2018. This may impact Indian pharma sector too. In words of Mr. Gupta, "The impact may not be immediate as people are not keen to go to China. There is language barrier and recession process is tough. It will take at least 5 years to establish."

FDA Today the U.S. Food and Drug Administration granted approval to Reblozyl (luspatercept-aamt) for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

"When patients receive multiple blood transfusions, there is a risk for iron overload, which can affect many organs," said Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research. "Today's approval provides patients with a therapy that, for the first time, will help decrease the number of blood transfusions. This approval is an example of our continued progress for rare diseases and providing important new drugs to patients earlier."

Beta thalassemia, also called "Cooley's anemia," is an inherited blood disorder that reduces the production of hemoglobin, an iron-containing protein in red blood cells that carries oxygen to cells throughout the body. In people with beta thalassemia, low levels of hemoglobin lead to a lack of oxygen in many parts of the body and anemia, which can cause pale skin, weakness, fatigue and more serious complications. Supportive treatment for people with beta thalassemia often consists of lifelong regimens of chronic blood transfusions for survival and treatment for iron overload due to the transfusions. People with beta thalassemia are also at an increased risk of developing abnormal blood clots.

The approval of Reblozyl was based on the results of a clinical trial of 336 patients with beta thalassemia who required RBC transfusions, of which 112 received a placebo. Twenty-one percent of the patients who received Reblozyl achieved at least a 33% reduction in transfusions compared to 4.5% of the patients who received a placebo. The transfusion reduction meant that the patient needed fewer transfusions over 12 consecutive weeks while taking Reblozyl.

Common side effects for patients taking Reblozyl were headache, bone pain, arthralgia (joint pain), fatigue, cough, abdominal pain, diarrhea and dizziness. Patients may experience hypertension while using Reblozyl. Health care professionals are advised to monitor a patient's blood pressure during treatment and to initiate anti-hypertensive treatment if necessary. Patients who receive Reblozyl should be monitored for thrombosis (blood clots). The FDA advises health care professionals to tell females of reproductive age to use effective contraception during treatment with Reblozyl. Women who are pregnant or breastfeeding should not take Reblozyl because it may cause harm to a developing fetus or newborn baby.

The FDA granted this application Fast Track designation. Reblozyl also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. The FDA granted approval of Reblozyl to Celegene Corporation.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.