Simplicity and Harmonization of Regulatory Requirement for Generic Products

Simplicity and Harmonization of Regulatory Requirement for Generic Products

In the era of globalization, every field and area is trying for globalization as well as harmonization. Similar to other areas like IT, Automotive sector, Pharmaceutical field is also trying for globalization. The impact of globalization makes Indian pharmaceutical industry recognizable in the world. Many of the Indian Pharma companies are leading in the supply of medicines and compete for the generic market. Many companies like Ranbaxy, Wokhardt, Lupin and Dr. Reddy’s are manufacturing the products for Indian market as well as global market, whereas Aurobindo Pharma Ltd. aims specially for the global market and doing the best.

The generic market is divided by region and country wise. This division is based on the regulatory requirement for particular country. We all know about the “International Conference on Harmonization” and practice it in the routine development. All over the globe we are following the ICH guidelines in Pharmaceutical Industry and accepted to all. The generic products development involves many requirements like active and inactive pharmaceutical ingredients, pharmaceutical equivalence, stability, patents, bioequivalence study etc. The basic and stringent requirement for any generic product is that it should be bioequivalent to Innovator product.

Each and every country or region has their regulatory body to control the drug manufacturing and marketing. These regulatory bodies laid the regulation that products registered first in their regulatory body must be taken as Innovator sample for bioequivalence study. So the generic pharmaceutical company has to do two-bioequivalence studies for two different countries, even though the Innovator Company is same in both the countries. This causes the rise in product cost. Proper harmonization is necessary in this regard. When the Innovator Company is same, only one bioequivalence study should be sufficient for registering the product in different countries. Further, even if the innovator is different but the dosage form is same, the In-vivo In vitro correlation (IVIVC) should be accepted for registration. If there are different strengths in different countries, then also application of IVIVC (depending on Pharmacokinetic behavior) should be considered for registration. This harmonization will result in cost effective products and it will be beneficial to government as well as public.

Recently, Aurobindo got an opportunity to hear Mr. Sultan Ghani, Director, Therapeutic Products, Health Canada. In his speech, he has focused on harmonization of regulatory requirements of different countries and how effective and beneficial it will be for Government, Pharmaceutical Industry and Public. USFDA, MHRA, Health Canada etc. should come together and lay combined regulations to cover all the possible country’s regulatory requirements. If this is achieved, then we will have only one filing of the product, one audit, one BE studies and etc. By saving time, money and resources, we can further think of better global healthcare.


Shamkant Shimpi, Ph.D.
Working as Scientist in Aurobindo Pharma Ltd., Hyderabad.