Department of Pediatrics, University College of Medical Sciences, Dilshad Garden, Delhi, India.
Email: [email protected]
   

A generic drug is a drug which has the same constituents, dosage form, strength and quality as the reference/branded drug and is marketed under a non-propriety name after expiry of the original drug patent [1]. The Government of India recently announced its mandate to stop issuing license for the manufacture or sale of branded drugs in an effort to promote prescription of only generic drugs for patient care, applicable at all government hospitals [2]. It launched the ‘Jan Aushadhi’ campaign for distribution of these generic drugs [3]. The above policy was introduced to curb the presumed malpractice associated with use of branded drugs, wherein the doctors’ prescription may be biased by pharmaceutical companies. Thus, it was anticipated that by prescribing only generic drugs, the malpractice of dispensing costlier medications would be reduced.

However, the following facts need mention to comprehend the present situation. First, the production and availability for most of the generic drugs is limited to few Jan Aushadhi stores, which have insufficient stock of medicines or are non-functional [4]. The only source of medication-provider for the patient is thus the local pharmacy. This leaves the patient to the mercy of the dispenser, who can dispense any brand available for the generic drug prescribed and supposedly make the ‘most suitable’ drug choice for him. Second, many patients attending the government sector are illiterate and less versed with medical terms or drugs. This puts them at a higher risk of being cheated by drug dispensers, whose business strategy concentrates chiefly on maximizing monetary profits. At times, some pharmacists are unqualified and insensitive to patient’s condition, unlike most physicians who might think twice before advising a costlier medicine to a poor patient. Majority of the drug market is unregulated, which is apparent by the wide price range of the same drug manufactured by different companies. Currently, there is no strict quality-control to monitor the constituents or price of every brand available in the market.

A glaring example of misuse of generic drug policy is highlighted. A resident doctor, following the government’s policy, prescribed oral amoxicillin-clavulanic acid (as a generic drug) to a child as a switch-over therapy after recovering from severe pneumonia. Almost 602 brands of amoxicillin-clavulanic acid are available; most reputed brands in syrup form cost approximately Rs.50-60 per 30 mL bottle for 200 mg/5 mL formulation (Rs. 40-50 per gram amoxicillin) [5]. However, this patient was dispensed a local brand which was costlier by about 3 times the well known brands (Rs. 101 for 30 mL bottle for 125 mg/5 mL formulation amounting to Rs. 134 per gram of amoxicillin). This brand – and its price – seems to be designed just to cheat the ignorant customers, as apparent from the manufacturer’s attempt to simulate the label graphics of another well-known brand (Fig. 1). The mother, having a poor financial status, was obviously worried about the higher cost of this drug in comparison to the estimate given to her by the resident doctor, and returned back to us to check.

Fig. 1: High MRP quoted on packaging of the concerned product.

The above cited example is just one of the many instances of drug mal-dispensing that go unnoticed. Therefore, it is essential to develop a fully functioning generic drug production and distribution market before we change to an ‘only generic drug’ policy. Simultaneously, there should be strict monitoring of quality and price of drugs to prevent manufacture of sub-standard and irrationally priced products. The rationale of prescribing a generic drug can only be justified thereafter in patients’ best interests.

1. Generic drugs. Trade, foreign policy, diplomacy and health. World Health Organisation. Available from: http://www.who.int/trade/glossary/story034/en/. Accessed July 15, 2014.

2. Directorate General of Health Services. Ministry of health and family welfare. Government of India. Order number S-11025/45/10-MH-I, dated 26th may 2010. Available from: msotransparent.nic.in/writereaddata/cghsdata/mainlinkfile/File201.pdf. Accessed July 15, 2014.

3. Jan Aushadhi. Generic Medicine Campaign Improving Access to Medicines. Available from: http://janaushadhi.gov.in/. Accessed July 16, 2014.

4. 33% of generic medicine stores non-functional. Times of India. 2014. August 08; New Delhi: page 13 (col 2-3).