Indian pharma: We're stymied by 'overzealous' drug regulators
- At CPhI Paris, two high-level government officials complained openly that the Indian drug industry is being over-regulated by outside agencies because of quality-control concerns.
- There have been numerous ongoing reports about recalls of drugs manufactured in India due to poor quality.
- India is the epicenter of low-cost drug manufacturing, providing much-needed pharmaceuticals for many parts of the world—including the U.S., where 10% of finished drug products are manufactured in India.
It's true: the Indian pharmaceutical industry has an image problem. Numerous reports of product recalls, including 428,000 bottles of venlafxine in May,10,200 bottles of promethazine in June, and 40,000 bottles of venlafaxine in July (to name just a few) have called into question whether manufacturing practices are in general alignment with good manufacturing practices in India.
On the other hand, India's pharmaceutical industry has implemented numerous innovative measures that make it possible to manufacture drugs more cheaply than they are elsewhere. As the leading producer of low-cost medications, India not only serves markets in developed countries, such as the U.S., but it also provides much-needed medications to patients in less affluent countries. In fact, India supplies 80% of the donor-funded drugs used to treat AIDS patients.
So where's the balance? India has more than 10,000 pharmaceutical manufacturing facilities that create products destined for 15 different markets. Some—but not all—of the facilities are approved by the FDA, the World Health Organization, or the European Medicines Association. Obtaining approval from one of these bodies is expensive and could result in price increases. Therefore, the Indian government is calling for standardized regulations among all of the regulatory agencies to allow Indian facilities to have one target that they can work towards. In the mean time, production continues as demand in the region continues to grow.
- In-pharma Technologist Global regulators demanding needless drug quality levels, says Indian Gov