5440 dedicated retail outlets selling affordable generic medicines are functional

Under Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP), a total of 5440 dedicated retail outlets selling affordable generic medicines are functional in the country as on 15.07.2019.

There is no definition of generic or branded medicines under the Drugs & Cosmetics Act, 1940 and Rules, 1945 made thereunder. However, generic medicines are generally those which contain same amount of same active ingredient(s) in same dosage form and are intended to be administered by the same route of administration as that of branded medicine. Further, drugs manufactured in the country, irrespective of whether they are generic or branded, are required to comply with the same standards as prescribed in the Drugs and Cosmetics Act, 1940 and Rules, 1945 made thereunder for their quality. As such they are expected to have similar effects.

The price of an unbranded generic version of a medicine is generally lower than the price of a corresponding branded medicine because in case of generic version, the pharmaceutical company does not have to spend money on promotion of its brand. The sale of a generic version is incentivized by a pharmaceutical company by keeping a high trade margin for wholesalers and retailers.

Medical Council of India (MCI) has notified an amendment in Clause 1.5 of Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 vide notification dated 21.09.2016, which stipulates that “Every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drugs”. MCI has further issued a circular on 21.04.2017 vide which all the Registered Medical Practitioners under the Indian Medical Council (IMC) Act have been directed to comply with the aforesaid provisions. The Minister of State (Health and Family Welfare), Sh Ashwini Kumar Choubey stated this in a written reply in the Rajya Sabha.

The quality of drugs imported, manufactured and sold in the country is regulated under the provisions of Drugs and Cosmetics Act, 1940 and Drugs & Cosmetics Rules, 1945 made there under. There is no definition of ‘generic drugs’ in the said Act & Rules. However, generic medicines are generally those which contain same amount of same active ingredient(s) in same dosage form, and are intended to be administered by the same route of administration as that of branded medicine.

 The medicines, whether branded, generic or branded-generic, imported or manufactured for sale/distribution in the country, are required to comply with the same standards as specified in the Second Schedule to the Drugs and Cosmetics Act, 1940.

These medicines are available easily in the country, especially in Delhi. Further, “Public Health & Hospitals” being a State subject, the primary responsibility of ensuring the sufficient supply of free medicines is that of respective State Governments.

Under the National Health Mission, the Central Government supplements the efforts of State Governments to strengthen their healthcare system including for provision of free essential medicines in public health facilities, based on proposals of the State Governments.

Under the NHM, financial and technical support is provided to the States/UTs not only for provision of essential drugs (mostly all generic), free of cost, in public health facilities but also for strengthening/setting up robust systems of procurement, quality assurance mechanism, warehousing, prescription audit, grievance redressal, dissemination of Standard Treatment Guidelines, and IT backed supply chain management systems like Drugs and Vaccines Distribution Management Systems (DVDMS).