The Indian Pharma companies were seen on a buying spree previous year for winning the big share of the generic drugs of the U.S. market. The trend has picked up momentum because of the stringent standards of the U.S. for the Indian facilities of the drug makers. A lot of Indian Pharma companies have failed on their scrutinisation in terms of safety and a wish to develop as well as sell sophisticated products like strong painkillers. According to the U.S. regulators, these medicines should be manufactured in the domestic market. Last year, the overall reach of the Indian Pharma companies was valued at a whopping $1.5 billion.
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The EU and the U.S. regulations have asked the Indian Pharma sector to improve the standards of manufacturing and also to ensure reliability of the data if it’s for maintaining its dominance in generic drugs domain. India’s pharmaceutical industry which has been valued at $15 billion is a rapidly increasingly global supplier of cheap generic medicines but it is lagging behind due to quality concerns after U.S. foods and drugs administration banned a couple of factories from manufacturing medicines.
Top Reasons Why Indian Pharma Companies are Not Making Drug
The EMA (European Medicines Agency and the medicines and health regulatory authority of UK even restricted some of the Indian plants from manufacturing drugs to be sold in their markets.
The officials from U.S., UK and EU regulators said that they are planning to increase the inspections in the Indian Pharma market and are also pushing for a better cooperation between the Indian companies and authorities and improved training for medical staff.
Still some Indian pharmaceutical companies are not taking sufficient steps for identifying risks as well as failures at their plants.
A culture also needs to be created where the employees may be able to report about something fishy to their superiors.
People really respect authority in India but it may become a weakness if everyone starts closing their minds and listen to just the authorities in place of doing the right things.
At present India is supplying approximately 33% medicines which are sold in U.S. markets and approximately one quarter sold in UK.
The complaints from the regulators have also highlighted various issues like maintenance and hygiene to concerns over the falsification of manufacture related tests, data and results.
The Pharma Franchise Companies in India have also said that they’ve been working to improve their standards of manufacturing by bringing in the 3rd party auditors, staff for training and automating their current systems.
The market leaders of the Indian Pharma market including Lupin ltd., Sun Pharmaceutical Industries Ltd., Fossil Remedies, Ambit PCD Pharma, Cadila healthcare ltd. etc have supported all these commitments.
Dilip Sanghvi, the founder of Sun Pharma has also said that he is expecting automation of the systems at all the manufacturing plants of the company in the coming 3-4 years.
So, all the above mentioned reasons contribute to the fact that the Pcd Based Franchises Companies in India are not willing to manufacture their drugs in the domestics market.