New Delhi: The Indian pharmaceutical industry is one of the most attractive investment destinations in the world. With ever increasing returns, lowering risks and anticipated multifold growth, investors are more interested in this industry than ever before. Global players are facing stiff competition with Indian manufacturers in terms of price, quality and commitment.
India is the first country in the world with approximately 700 USFDA approved plant that is why Indian companies are under scanner of USFDA. In 2014, the Office of Manufacturing Quality of USFDA had given only five warning letters to Indian companies out of a total of 19 issued. Out of the eleven warning letters issued so far by the Office of Manufacturing Quality of the US FDA this year-2015, six were issued to India-based drug companies. More Indian drug companies were coming under the FDA lens because of the huge volume of drug production from the country.
Data management is an important issue for many drug companies worldwide which often attracts scrutiny from the regulators. The FDA does not discriminate against any particular company or a nation”, Howard Sklamberg, the US FDA Deputy Commissioner for Global Regulatory Operations and Policy had told in March, while reacting to allegations that Indian drug companies were increasingly found guilty of poor data maintenance and in many cases falsified data.
The EU has banned the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by GVK Biosciences. There was ECG data extra but due to that our nation suffered USD 1.5 billion loss.
Indian manufacturers, marketers and exporters are facing intolerance from all fronts in India as well such as NPPA, FSSAI, CDSCO, Special Economic Zone and pharmaxil. Definition of new drug approval in terms of NPPA is different to that of CDSCO. According to NPPA new drug means that drug manufactured after 2013 will be considered as new drug and manufacturer has to get price fixation.
According to CDSCO new drug remains four years from the first date of approval in India. No time table is there in CDSO for approval whether it is Drugs, API, Medical device or Cosmatics. CDSCO has issued phase-4 clinical trial query to small scale manufacturer and this term is not known to them. No body from CDSCO side tried to organise workshop with the manufacturers before issuing query letter. It is responsibility of Dr.V.G.Sumani, Joint DCGI who heads FDC division.
For nutraceuticals export registeration GMP certificate is required from importing country but FSSAI people are sleeping and they are not worried about the losses to the nation. FSSAI made high level of intolerance in the name of product approval and collected huge amount of money from application fee. There is Rs.15000 fee for application of new drug in CDSCO but with FSSA it was Rs.25000 per application. FSSAI made fool to industry uptil now because product approval was against the FSSAI-ACT.
Pharmaxil has organised tour recently with 50 companies to kazakistan, Uzbekistan and Tajikistan and charged Rs.50, 000 per person for organising meeting with buyers only. Not a single buyer turned up in all three countries except consultant. It shows pharmaxil is not vigilant in their job assigned to them and the services they are providing to the industry. A very sand news from kala amb and Pauntasahab, himachal Pradesh, 120 factories has been shut down as reported by the local newspaper.
Mohammad Shahbaz Alam