In Retrospect

Generic drugs: A healthier tomorrow

For long, private companies have ruled their reign in pharmaceuticals causing dramatic over-pricing of even basic medicines. With its new policy of introducing large-scale generic drugs, the government aims to stop this malpractice. Is this only good news, or is too sprinkled with possible pitfalls? Write Dhirendra Kumar and Radhika Dutt.

Falling ill has been the average citizen's biggest woe. Not only because it adversely impacts the body – but primarily because it leaves irreplaceable trenches in our pockets, and empties out bank accounts in a jiffy. Tapping on to the woes of the population, the central government with its acting policy on generic drugs is aiming to curtail the sky rocketing prices of branded medicines that have long been disturbing the population of India. A recent study by the WHO suggests that the average Indian spends 70-80 per cent of their income on healthcare. The rising numbers have drawn the notice of our wise men who have now taken up the initiative to revolutionise the healthcare system in the country. The well-known National Pharmaceutical Pricing Authority (NPPA) has been mandated with the responsibility to overlook the smooth infiltration of generic medicines into the drugs market of India.

Generic medicines are similar if not the same as their branded counterparts, only, they cost significantly less, as they come without the tag of the parent manufacturer. This change is of paramount importance in an economy like India's where about 20 per cent of the population suffers from chronic diseases and 27 per cent of deaths occur due to want of medical attention. Prime Minister Narendra Modi, and the NITI Aayog have been working silently to bring about a rapid change in the entire healthcare structure. "It is the government's responsibility to ensure that everybody has access to healthcare at minimal prices," said Prime Minister Modi echoing what most of the nation felt. To turn this dream into reality the government has set up Pradhan Mantri Bharatiya Jan Aushadhi Kendra(s) (PMBJK) to make generic medicines available to the population at affordable prices. So far, there are 1320 PMBJKs across 30 states and Union Territories, covering 426 districts. The government has pledged to open 1000 more such outlets at railway stations across the country.

The first step to improve healthcare in the country was taken up by the West Bengal government, right after Mamata Banerjee came to power in 2011– the initiative which begun in 2012 had been seen as a model for the rest of the nation. Over a 100 fair price medicine shops have been opened across the state which provide drugs at a discount of 48-77.2 per cent. Not just medicine outlets, but also 58 fair price diagnostic centers had been set up in just 4 years, from 2012, offering digital X-ray, dialysis, CT Scan and MRI at affordable prices. Following suit, the Narendra Modi government too has taken up initiatives to make healthcare affordable to all citizens of the country. A starting step in the right direction could be the popularization of generic drugs among the masses. The Union Minister for Chemical and Fertilisers, Ananth Kumar propagating the government's bold move has vouched that the government through Jan Aushadhi Pariyojana is creating a silent revolution in achieving health security by providing affordable, quality medicines to all. "Under the Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana (PMBJP), the government is planning to take affordable medicines to each block of the country in the near future. Since making quality medicines available at affordable prices has been a key challenge, the government would reinvigorate the supply of generic drugs by opening 3,000 stores under the Prime Minister's Jan Aushadhi Yojana during 2017. At the PMBJKs, only generic medicines procured by the government are sold, which cost 50 per cent to 90 per cent less than the branded medicines in the open market." said the Minister.

Despite this move coming about to ensure holistic wellbeing of the average Indian citizen fraudulent activities have already been brought to notice. In a shocking revelation, it has come to the notice of the NPPA that about 60 drug manufacturers have violated various provisions of Drug (Prices Control) Order, 2013, and introduced 'new drugs' by altering scheduled formulations to be auto-exempted from the price-capping order of the government.

The NPPA has scrutinised 60 pharmaceutical majors where 201 'new drugs' have been put under scanner. According to sources, pharmaceutical companies such as Abbott Healthcare, Alkem Laboratories, Codila Pharmaceuticals, GlaxoSmithKline, Lupin, Novartis India, Ranbaxy Laboratories, Sanofi India, Zydus Cadila, etc have introduced new drugs by slightly altering the composition to be able to dodge price-capping. According to officials at NPPA, the non-compliance of the order came into notice of the regulator during compliance monitoring of various norms of the Drug (Prices Control) Order by drug manufacturers. The concerns regarding fraudulence by pharmaceuticals are echoed by doctors too.

Dr Jaya Deb Barman, Clinical Associate of the Medicine Department at Asian Hospital, says, "If we as doctors begin to subscribe only generic compositions then the pharmacists get complete control to choose the drug to sell. Very often a composition is available between Rs 1100 – Rs 3500, and pharmacists would sell the Rs 1100 drug for Rs 2500, profiting the rest. Also, pharmaceutical companies tie up with medicine shops to ensure that their drug is sold most frequently irrespective of the availability of cheaper drugs, as they are promised some commission off sales," she adds.

A branded drug often comes with an unsaid assurance of quality. As Ram Manohar Lohia Hospital's orthopaedic surgeon Durga Shankar told Millennium Post, "A doctor is well informed about the response of a drug, whether generic or branded, on their patients, which is not the case with medicine sellers." Shankar further said, that undoubtedly the move is commendable, but there is an urgent need to fix the responsibilities. "We doctors have no objection in prescribing generic drugs, but we are skeptical about its quality and doubtful that poor patients would fall prey to unethical practices of pharmacists." Emphasising on the need to govern the quality of generic medicines professor at Centre for Social Medicine and Community Health, at Jawaharlal Nehru University, Ritu Priya said, "Availability of generic drugs is not a major issue; the major concern is its quality. At present, the government has no mechanism to authenticate the quality of drugs, which is a very serious issue. It is true that patients would get generic drugs at much lesser prices, but what about its efficacy. I hail the government's move, but at the same time I would suggest them to strengthen the State Drug Controllers (SDC), which are in a deplorable state. The SDCs have no staff to examine the quality of drugs and if the government takes some concrete initiative in this direction, only then would our healthcare system improve."

Globally the story of generic drugs has been more positive, and maybe it is too early to dissuade India from taking what appears to be a very important step. USA, a country which faces highest cost of healthcare introduced the Drug Price Competition and Patent Restoration Act in 1984, for the recognition of generic drugs. This was followed by the Generic Initiative for Value and Efficiency (GIVE) launched by the Food and Drug Administration (FDA) in 2007, which was an attempt to modernise the process of approving generic drugs and to rapidly increase the number and variety of generic drugs available. In the USA the FDA that overlooks the functioning of the generic medication market has said that consumers who have replaced generic medication with their branded counterpart are able to save up to 52 per cent of their income on daily drug costs.

The success of generic medicines has flourished even in developing nations like Mexico. In 2007, generics accounted for 44 per cent of all medical drugs sold in the country, by the end of 2011 the share had reached to 71 per cent, and till 2014 it touched 84 per cent. The North American market is led by the US Generic Market which is forecasted to reach $112 billion by 2020.

The overshooting prices of branded medicines in the USA had compelled this move that motivated consumers to subscribe to generic medicine ahead of seemingly trustworthy branded companies. North America remains the most lucrative market for generic medicines with large-scale imports and exports both taking place in this region. Europe is still in the stage of developing, as they are bringing in more regulation in prices of generic medicines. Research suggests that the generic drug market of Central Europe will see a 3-6 per cent per annum development between 2016 and 2021.

While the use of generic medicines within India is yet to reach its optimum, India is the largest supplier of cost effective generic medicines to the developed world. The growing Indian pharmaceutical industry is expected to reach $50 billion by 2020. The Indian government is now taking steps to familiarise the use of generic medicines. Yet, before such a rapid move is taken across such a large population there are several impediments which have to be battled.

The move to refurbish pharmaceutical pricing in India may be the beacon of a healthier and more affordable future, but in a population with quantity as proliferating as ours the concerns over quality must never be ignored.
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