This is an undisputed fact that today India’s pharmaceutical is a force to reckon with. Industries related to Pharmaceutical Formulations in India and Research and Development in India have been instrumental in garnering sales of approximately rupees two lac Crore worth of medicines and vaccines; produced and supplied by a seven thousand strong manufacturing hubs spread across the country.
The country’s pharmaceutical industry not only caters to the domestic markets, but also exports formulations to more than two hundred countries spread across the globe. No wonder that in the international pharmaceutical circles, India is termed as the ‘pharmacy of the global south’.
Allopathic drugs, conventionally, have been initially discovered, manufactured and devoured as Active Pharmaceutical Ingredient, or APIs, as they are generally known. Generally, the APIs or Active Pharmaceutical Ingredient and formulations are found after at least twelve to fifteen years of thorough clinical trials and research.
They are then introduced into the healthcare sphere only when they can satisfactorily conform to the stringent safety and efficiency criteria of the chemical or biological therapies or sometimes both. In recent years though, it’s coming to the forefront that pharmaceutical companies in India are merging more than one API to come up with something called Fixed Dose Combinations, or FDC.
Most FDCs are not tested for their safety and efficacy in clinical trials in many part of the world; hence, due to their notoriety, such FDCs are found rarely in the regulated markets. But in India, the menace of FDCs is quite widespread.
Approximately 40% of the Indian market for drugs constituents for FDCs, generating revenues worth hundreds of millions of dollars for the pharmaceutical firms. It is important to identify irrational and rational FDCs in order to make an informed decision. Some of following points can help you make the distinction.
A Look at Rational FDCs:
- The blend of ingredients conforms to the needs of the specified population group
- When its proven that the FDC is definitely beneficial against single API compound
- The combination is not toxic in nature in consumption
- Examples: sulfamethoxazole + trimethoprim; rifampicin + isoniazid, isoniazid + ethambutol (for Tuberculosis) and levodopa + carbidopa (for Parkinson’s Disease)
- The FDC would be considered irrational when the above criteria aren’t met
- One example is nimesulide + paracetamol formulation that is used for paediatric care
Over the years, the outsourcing wave has not just swept the Indian IT sector but also many other industries across the country, including the pharmaceutical empire. Today, one of the rising business fields in India worth having a discourse over is the Pharmaceutical Contract Manufacturing from USA.
Ciron Pharmaceuticals Inc. 