Finally, the central government launched the National List of Essential Medicines (NLEM) after a long gap of seven years. Blame Covid-19 or other unknown reasons for the delay as the NLEM is recommended to be revised more frequently — every two to three years — so that it can be responsive enough to include medicines as per changing health needs, epidemiological trends, scientific advancements, and knowledge.
Without going into technical details, this is the list that becomes a guidance document for the procurement of medicines by central and state government healthcare facilities. It also guides doctors across the country in choosing the first line of treatment. The medicines that become part of this list fall under the price control mechanism and hence, become cheaper and affordable.
The making of NLEM is an exhaustive process as it includes multiple consultations with a variety of stakeholders where the pharma industry tries hard to influence panel members to keep their products outside the list.
While the newly released list has many positives and brings multiple new drugs such as anti-diabetic, anti-cancer and anti-TB under price control, glaring gaps still remain. The updated list has deleted 26 drugs from the previous list and added 34 drugs, increasing the list to 384.
Lost opportunity on adding more anti-cancer drugs
One front where the list fell short of expectations is the inclusion of a few more cancer drugs. Most of the high-priced, effective treatments for various cancers have not been included in the list.
India’s NLEM, as explained by various government officials involved in the making of the list, is inspired by the World Health Organisation (WHO)’s list.
Still, India’s list of cancer therapy inclusion does not seem as elaborative as that of the WHO. In fact, in recent years, WHO has taken steps to expand the cancer section of the global Model Essential Medicines List.
Malini Aisola, a health activist who represents an NGO called All India Drug Action Network (AIDAN), believes that “India has passed up an opportunity to make many useful cancer treatments, currently priced beyond the reach of the majority of people, more affordable and accessible”.
According to government estimates, the number of Indians suffering from cancer is projected to increase to 2.98 crore in 2025 from 2.67 crore in 2021.
Why Teneligliptin and not Sitagliptin?
Another miscalculation probably is the addition of the anti-diabetic drug Teneligliptin instead of Sitagliptin.
Until the last few weeks of fine-tuning the list, as per the two highly placed sources I have been in touch with, Sitagliptin was part of the draft NLEM and was expected to be one of the showstoppers of the entire exercise.
The reason: India is a country with more than 77 million diabetics and many of them were prescribed the drug, sold under the popular brand name Januvia.
While the drug has recently expired its patent, it still costs Rs 38 per tablet for MSD’s Januvia brand whereas other generic versions are cheaper and cost around Rs 12 per tablet.
Rather, the government has brought Teneligliptin under price control, which is Rs 7.5 per tablet.
Data by IQVIA, a health research firm, shows that in the month of August, 40.77 lakh strips of Teneligliptin were sold whereas 29.44 lakh strips of Sitagliptin were sold. However, while calculating the lesser market share of Sitagliptin, we must consider that the drug’s patent just expired in July 2022. Hence, it’s too early to compare its market share with other generics.
Sitagliptin is known for not causing low blood sugar episodes and is backed by robust data with minimal side effects. Doctors told me that they have started shifting patients to Sitagliptin as it became slightly affordable post patent expiry.
Here, the approach to include a drug with higher sales or market share seems invalid as Teneligliptin was already reasonably priced. Moreover, efficacy-wise, Teneligliptin is not considered a supreme formulation over Sitagliptin, which is considered the latest molecule in the anti-diabetic drug market.
“Sitagliptin has robust data on heart safety behind it which is not the case with Teneligliptin,” renowned endocrinologist Anoop Misra, executive chairman, Fortis C-DOC Hospital for Diabetes and Allied Sciences, told me over a WhatsApp chat. “Teneligliptin was already a cheap drug.”
Also, the list did not consider the need to include more synthetic insulins and other classes of oral anti-diabetics for the booming population of diabetics in India.
Faulty price control formula
The faulty price control mechanism may make the exercise futile to an extent.
These 384 drugs will now come under drug pricing control order – pricing laws – and in the next three months, drug price watchdog, National Pharmaceutical Pricing Authority (NPPA), will finalise the maximum retail price (MRP) of these drugs.
The ceiling price is fixed on the basis of the simple average price of all brands (in that formulation category) having at least one per cent market share of the total market turnover of that drug.
But how will this formula work for patented drug categories such as anti-TB drug Bedaquiline and Delamanid where the patents are set to expire in 2023 and no other drug is available in the entire category for calculating the simple average?
“Similarly, a variety of cancer drugs added to NLEM cost almost the same in the range of Rs 3,000 to Rs 5,000 where the simple average formula will not drive costs into the bracket of affordable drugs,” KM Gopakumar, an expert in global intellectual property regime, shared his analysis over a call.
Sample this: Anti-cancer drug Bendamustine Hydrochloride, which works by damaging the genetic material of the cancer cells, has been added to the list.
The simple average of the drug, which is manufactured by Dr Reddy’s (Rs 3,981), Natco (Rs 3,643), Panacea Biotech (Rs 2,684), Pfizer (Rs 9,503), Jannsen (Rs 5,500) and Celon (Rs 9,000) comes to around Rs 4,900, assuming that they all have at least 1 per cent market share.
However, a ceiling price of Rs 4,900 hardly makes the drug affordable.
Super hits in the list
Widely used injectable antibiotic Meropenum is included in NLEM, the price of which is likely to come down to Rs 1,200 per injection against the present cost of over Rs 2,000.
Meropenum is commonly used to treat critically ill patients admitted to hospital and the drug is prescribed usually for at least five days. A three-times-a-day dose adds up to more than Rs 20,000 in a patient’s hospital bill. Some brands also cost as high as Rs 5,500.
The drug is the first line of defence mechanism that every hospital gives to the patient as soon as he/she is admitted and occupies a notable chunk of the hospital bill for patients. Pharma companies, including AstraZeneca, Zydus Cadila, Cipla, Novartis and Sanofi, are the manufacturers of the product.
It is a welcome move that the diabetes section has been expanded to include insulin Glargine (Lantus). The list also adds nicotine replacement therapy, which is deemed to be a significant move, as a pack of nicotine gum costs more than a pack of beedi or gutkha. Hence, making such therapies affordable is an important step.
Products which were obsolete, like the hypertension drug Methyldopa, were deleted and those with already very low maximum retail prices such as Erythromycin and Ranitidine were also excluded.
The government panels also debated over the exclusion of anti-infective drug Metronidazole but since it’s in NLEM of many developed countries, it was not taken off.
Overall, the effort to re-construct the list, instead of the usual copy-paste, is an appreciable attempt. However, it still lacks a punch.
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