Alarmed by quality of generic drugs in the country, the Drugs Controller General of India (DCGI) has called upon pharmaceutical analysts to make strong commitment to ensuring drug quality.
It has been argued that branded drugs are superior in quality and efficacy as compared to generic drugs. Pharmaceutical analysis determine the quality of drug products through the test of analytical chemistry. They are responsible for release of batch and play a crucial role in ensuring quality medicines reach patients. They should never bow down to any pressure in issuing quality certificates to substandard products threatening public health, said Dr S Eswara Reddy, DCGI, while addressing IDMA–APA Pharmaceutical Analysts’ Convention (PAC) 2018 in Mumbai recently.
Branded generics are costly, while generics are far cheaper and are sold by just the salt name. Despite being expensive, branded generics account for 85 per cent of market share because doctors prefer to prescribe branded drugs over generic drugs. Most of them have expressed concern over quality and efficacy of generic drugs.
The Central government has taken a series of steps to promote quality generics in the country so that people can access drugs at affordable price. For medicines manufactured and sold in India, the product permission is granted in generic name. Union health ministry has made it mandatory for any drug to conduct bio-equivalence studies in India before they are launched in the market.
The government is also planning to make it mandatory for drug stores to display generic medicines on separate shelves so that consumers can purchase cheap alternatives to costly branded medicines. The Drugs Technical Advisory Board (DTAB) has agreed to the proposal in this regard.
In 2016 the Medical Council of India had directed doctors to prescribe generic drugs.
DCGI added all these initiatives are part of government's mission to ensure availability and accessibility of quality drugs for patients. The pharmaceutical industry and drug regulator need to work together in the interest of patients.