As per the National Sample Survey on healthcare in 2014, ‘medicines emerged as a principal component of total health expenses — 72 percent in rural areas and 68 percent in urban areas’. It is, therefore, pertinent that their prices be regulated effectively and quality control ensured.

Drugs in our country are sold in two forms. First come the branded drugs, which are promoted by the manufacturers and given specific trade name by the company. Since their cost involves several promotional expenses, their price is higher. At least 90 percent of the Indian domestic pharmaceutical market of Rs 1,00,000 crore and more comprises drugs sold under brand names.

The concept of generic drugs was evolved to cut down this excess cost involved in packaging and other promotional means. The Indian government began encouraging more drug manufacturing by Indian companies in the early 1960s. Public sector pharmaceutical units played a vital role in this. A generic drug is sold under pharmaceutical/chemical name and has equal efficacy to the branded drugs. These are marketed under the chemical/pharmacological name without advertising. However, here too, companies started manufacturing them under brand names. These are termed branded generic drugs, which are being sold not under pharmacological name but under a different brand name even though produced by a company which is involved in manufacturing and promoting branded drugs.

To facilitate the use of generic drugs the government of India has set up Jan Aushadhis, which sell only generic name medicines. There are not enough Jan Aushadhis, possibly less than 3,000 against more than eight lakh retail outlets selling branded drugs.

Through the Indian pharma’s field force numbering nearly one million medical representatives, there has developed trust among the doctors and also the patients in the companies and their brands. For similar trust to develop on the generic drugs there is need for perceptible quality assurance. Otherwise the use of generic drugs is unlikely to increase.

With value of worth US $20 billion, the pharma sector in India is doing better than many other sectors and still continues to be the major source of supply of cheap bulk drugs globally even to some of the developed countries.

But there are also reports of low quality medicines. Spurious/falsely-labelled/falsified/counterfeit (SFFC) drugs can cause treatment failure or even death. This is unacceptable. A working paper published through the U.S. National Bureau of Economic Research gave details of the results of an extensive investigation into Indian pharmaceutical quality. Around 1,500 India-made drug samples were collected from 22 cities throughout Africa and it was found that ‘10 percent of the antibiotic and anti-tuberculosis samples contained insufficient levels of the key active ingredients’. Most of those drugs were not counterfeit; they are legally made by legitimate companies. They contain some therapeutic elements, but probably not enough active ingredients to actually treat disease’.

There have been cases of default by some of the leading companies. ‘Ranbaxy was found guilty in a US court in May 2013 and had to pay over half a billion dollars in fines and settlements. In 2012, Ranbaxy was forced to recall millions worth of drugs after glass particles were found mixed with the raw ingredients used for its generic version of Lipitor. Dr. Reddy's Laboratories had to recall about 58,000 bottles of an ulcer medication because some of the pills were found to be contaminated’. According to Central Drugs Standard Control Organization (CDSCO) estimation, during 2003-2008, 6.3-7.5 percent of the samples were of substandard quality and 0.16-0.35 percent were encountered as spurious.

Such reports reduce confidence among the health providers and patients on drugs, more so on generic drugs. It may be noted that there is powerful propaganda against the generic drugs by the companies selling branded drugs. This propaganda also impacts the patients who invariably ask for the branded drugs from multinational companies. This can be countered through strict quality control on all drugs, particularly the generic drugs. Their trade margins have to be regulated. To enforce the regulations there should be surprise check of samples collected from the market. The CDSCO has to play a vital role in this. People’s confidence has to be built through public awareness and effective standardization of drug quality. More public sector pharmaceutical units should be opened as it is easier to exercise quality control on them. (IPA Service)