Context: The use of quality generic medicines holds plenty of promise to reduce the burden on the common man. However, India needs to ensure people have access to quality generic drugs.
About Generic Drugs
- Generic Drugs refer to a medication that is equivalent to a brand-name product in terms of its active ingredient, strength, dosage form, and intended use.
- It is marketed either by a salt or brand name. They have the same potency, quality, and implications and work in an identical manner as the branded medicine.
- India is the largest producer of generic drugs globally.
Need for generic drugs
- Reduce Out-of-Pocket Expenditure: In India, around 94 million people are pushed into poverty due to expenditure on healthcare. About two-thirds of the expenditure is incurred on medicines.
- Accessibility, availability and affordability: It may become available once the patent on the brand-name drug expires. This allows for competition in the pharmaceutical market, which often results in lower prices for consumers. This makes generic medicines price 30% to 70% less than branded medicines.
- Effectiveness: It works in the same way as their brand-name counterparts. They have the same intended use and are equally effective.
- Rise in the number of fatal diseases: It has increased over the years and the cost of medicines for such diseases is very high.
Challenges to generic drugs
- Falsified and counterfeit drugs: Due to lack of transparency in the licensing procedures of Drugs, and lack of quality facility, it has resulted in the increased supply of low-quality, spurious and substandard drugs.
- In 2018, the Central Drug Standard Control Organization (CDSCO) identified nearly 4.5 per cent of all generic medicines in the domestic market to be substandard due to lack of testing facilities.
- Counterfeit products have entered the supply chain with severe consequences, as seen in Gambia and Uzbekistan.
- Absence of appropriate scientific standards: Doctors do not prescribe a generic drug due to their lack of trust in the quality available in the Indian market, which lacks scientific standards in India.
- Lack of resources and manpower: Drug control procedures in India suffer from a lack of resources and manpower. Widespread corruption within the system makes matters worse.
- Problem of naming a fixed-dose combination (FDC): Many fixed-dose combinations (FDCs) drugs contain even 8 or 9 Active Pharmaceutical Ingredients. To prescribe a generic name for each of the eight or nine ingredients is a very tedious and impractical task.
- Guidelines by the National Medical Commission (NMC) make it mandatory for doctors to write generic drug names legibly and preferably in capital letters.
- Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP): To provide quality generic medicines at affordable prices. Prices of medicines sold through these outlets are 50-90% less than that of branded medicine prices in the open market.
- Free Drugs Service Initiative (FDSI) 2015: It was launched under the National Health Mission (NHM) on procurement of generic essential medicines at low prices, eliminating irrational medicines and unscientific fixed-dose combinations.
- Drugs Technical Advisory Board (DTAB) has recommended that retailers should maintain a separate rack/shelf solely for the storage of generic medicines sold in the proper name.
- Utilising anti-counterfeiting technologies for counterfeit drugs: Through imaging technologies, variable data printing of unique numbers or barcodes with speciality inks, including invisible inks, and with RFID.
- Strong regulatory framework: Strengthen and enforce regulations that ensure the safety, quality, and efficacy of generic medicines. Create a clear approval process for generic drugs to enter the market.
- Drugs Controller General of India need to work in close association with the pharmaceutical companies and local drug control authorities to combat the menace of counterfeit drugs.
- Research and Development Support: Provide grants or incentives to pharmaceutical companies to invest in research and development of generic versions of essential medicines.
- Pharmacy Incentives: Reward pharmacies for promoting and dispensing generic medications.
- API Sourcing: Ensure the sourcing of APIs from reputable and approved manufacturers, preferably those that adhere to Good Manufacturing Practices (GMP) to ensure the quality of drugs.