Your only child has a fever and cough; your doctor diagnoses a chest infection and prescribes an antibiotic. You present the prescription at the local Jan Aushadhi store where medicines are available for sale by generic names as opposed to brand names. Generic names mention the chemical ingredient of the drug and are sold at prices which may be 30% to 80% cheaper than the branded medicine prescribed. What would you do? That would depend on the financial constraints; if significant you would welcome the “windfall” opportunity of saving some money. On the other hand, if you keep abreast with news, you would have read the recent reports of the WHO, who warned of fake Ozempic, a drug for Type 2 diabetes and weight loss, in 14 countries around the world; and fake Botox wreaking havoc.
The scenario in India is not much more reassuring. 120 samples of drugs manufactured in Himachal Pradesh failed the test parameters last year. As per the MOHFW, India now has 8 Central drug testing laboratories and 22 State ones including Goa. Shackled by inadequate funding, these cannot cope with the millions of drugs available.
Further, the Central Drugs Standard Control Organisation (CDSCO) reported that the majority of State Licencing Authorities (SLAs) do not submit data on NSQs (Not of Standard Quality) and many who do, do so in inappropriate formats. In another report, 52 drugs tested (13 in State Labs and 39 in Central) were NSQ.
Of the 13, 8 failed during tests and 5 were misbranded. The USFDA uncovered serious lapses in quality control in the manufacture of generic drugs in India. These related to contaminated products, unsanitary conditions, poorly trained staff, and lack of transparency.
More recently, India-made eyedrops caused “superbug” infections leading to blindness and one death in the US. India-made cough syrup has also been under the spotlight from the WHO over the deaths of 90 children in Gambia and Uzbekistan from kidney failure. The syrups contained toxic industrial grade glycol rather than the safe but costlier pharmaceutical-grade glycerine. Against the background of these and many more examples suggesting poor quality control, it is easy to appreciate the conflict in opinions between the Indian Pharmaceutical Association (IPA) which opposes prescription substitution in Jan Aushadhi Kendra’s and the All-India Drug Action Network (AIDAN) which keeps pushing for it. A high-level committee of all concerned parties is proposed to find a solution to the safety versus cost issue.
It is important to understand the background to this issue. Brand-name drugs are typically more expensive because of the much higher initial costs to research, test, market and sell a new drug. As a result, drug makers receive exclusive rights (patent) for 20 years after a drug is introduced. Once the patent expires, other companies can produce cheaper generic versions of the drug, copying what already exists without the cost of research and development.
Presently, a new manufacturer does not require a DCGI license/ approval for manufacturing a drug which has been in the market for over four years; a State Drug Authority approval is adequate. The IPA maintains that “this gives room for many sub-standard products in the market,”. It therefore urges the Centre not to pursue the Drug Technical Advisor Board (DTAB) recommendation. AIDAN maintains that this should be left up to an expert panel to decide whether a branded drug in a prescription may be substituted by a generic one.
In order to get a stamp of approval from the FDA, a generic medication must be “bioequivalent” to its brand-name counterpart. This means that chemically the two must be pretty much the same, although manufacturers are allowed 20% variation in the active ingredient from the original formula.
However, while companies are required to get the chemical recipe of the generic drug close to the original, they aren’t required to show that the two versions are therapeutically equivalent, meaning that they don't have to do tests to make sure that patients respond to these drugs the same way they do the brand-name version. For example, the manufacturer of a generic blood pressure medication wouldn’t need to prove that its drug also lowers blood pressure. The regulators argue that because the chemical composition of the medication is the same, it is safe to assume that it will have the same effect.
The MCI (now NMC) the regulatory body for medical professionals attempted to make it mandatory for doctors to prescribe in generic formats. The IMA demanded that quality control must be established first.
The IMA also asked, if doctors are not allowed to prescribe branded drugs, then why are such drugs licensed at all, given that modern medicine drugs can be dispensed only on prescription of doctors of this system. It’s a bit like licensing the manufacture of a car but restricting its sale.
The opening paragraph was more than just an academic discussion. What if the parent opted to buy the generic product and the child’s condition deteriorated? Would this be ascribed to substandard drugs, or the doctor’s misdiagnosis and erroneous treatment? The general tendency would be to lay the failure of treatment at the doorstep of the doctor and either stab him, shoot him, or at best sue him to face a mandatory 2yr jail term (Sec.106 BNS Act). All the foregoing discussions would be immaterial. This is the reason for the resistance to prescribing by generic names. The allegation of a pharmaceutical/doctor nexus would shift to a pharmaceutical/Jan Aushadhi nexus.
The solution must compulsorily lie in establishing high standards of quality control so as to promote confidence in generics, and avoid “cough syrup” type incidents. It is reassuring that 36% of the 400 units inspected by CDSCO recently were closed for failing to meet standards. Better late than never.
(The author is a past IMA Goa State president and founder member of VHAG)