FDA Disapproves Indian Manufactured Medicines

fda, indian medicines

The Food and Drug Administration (FDA) has disapproved medicines manufactured in India imported to the U.S.  The FDA strictly observes the prescription drugs that come from Indian subcontinent.  The FDA authority has de-certified one of the manufacturers of medicines of India, who previously were granted to export prescription drugs to the U.S.  The FDA standards are not being met by the medicine factory manufacturers of India.  Therefore, the FDA is curtailing the “made in India” prescription drugs.  The FDA has basically dismissed Indian manufactured medicines.

The United States previously imported the brand-name medicines from Indian companies.  However, Workhardt Limited and Ranbaxy Laboratories were banned from the US sales of medicines, since it made many medicines from certain plants.  The FDA deducts yearly fees of $300 million to pharmaceutical companies that export medicines.  The plants were researched three different times in 2009, and again in 2013, and harmful ingredients were located.  The FDA continuously issued warning to the companies and Ranbaxy was penalized to pay $500 million.  According to the World Health Organization (WHO), around 20 percent of Indian drugs are considered bogus and around 12 percent unauthentic.  Many reasons exists to why the FDA is now disapproving the Indian manufactured medicines.

Previously, the FDA commissioner, Dr. Margaret Hamburg, took a trip to India, upon her visit she received mixed reactions from the people.  Dr. Hamburg attended a meeting with the food and drug makers and exporters of India.  The discussion was supported by the Federation of Indian Chambers of Commerce and Industries. In the meeting, the Indian manufacturers raised concerns about the authorization period of the latest drugs.

Additionally, Dr. Hamburg said the companies that export medicines to the United States should ensure that the supply of prescription drugs is harmless, secure, efficient and high standard.  She highly stressed in the meeting with manufacturers and regulators the quality and standards of the product really matter.  She also advised safety and quality go hand in hand and without these elements a patient is at higher risks of being exposed to dangerous side effects.

Furthermore, in the meeting with the Indian business leaders and companies, both sides reached a mutual understanding that the regulation of Indian medicine manufacturers by the US should be administered earlier, as it is very crucial.  The Indian companies will be showing their record to the FDA for approval when exporting medicines to the US.  The FDA has set up an institute of regulation of quality and safety of medicines known as An Office of Pharmaceutical Quality.

Moreover, the US Food and Drug Administration have lost its trust on the Indian prescription drugs recently.  The Federal Aviation Administration (FAA) degraded the evaluation of the organization that controls the business flights in India, and the outcome of this was that two of the airlines faced tremendous financial crisis.  Furthermore, a miniature and inexpensive automobile, Tata Nano, is famous amongst drivers in India, however, it does not qualify for the safety standards internationally.  Indians are still contesting to establish safety rules which have been always ignored.  The international committee is concerned about the safety which is why increased regulation is necessary to ensure the products shipped out India have met certain standards.  Some Indians are producing different products for international market and domestic market to meet the quality.

The FDA disapproval of Indian manufactured medicines has increased international concerns.  The Indian Pharmaceutical Alliance President, Satish Reddy said there is a requirement of implementing higher regulation standards on the pharmaceutical companies.  However, it is not fair to say that all Indian medicines are infested.  According to one of the chairman of company of medicine, Yousuf Hamied told that Cipla, a prime manufacturing company abides FDA rules, and exports more than 55 percent annually of its medicines.  Some believe that the United States is increasingly becoming dependent upon Chinese exported goods which the FDA would not deny easily.

By Iqra Amjad


American Livewire
Austrian Tribune
Times of India

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