GSK, Sanofi may have negative impact after inclusion of their drugs in Essential Medicines List 2022

GSK, Sanofi may have negative impact after inclusion of their drugs in Essential Medicines List 2022

GSK would have to reduce prices for its antibiotics Ceftum and T- Bact which cumulatively cover around 15% of its sales, while Sanofi would have to reduce prices for Lantus - an opthalamic drug that has a fair share of 22 per cent of its sales.    

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 The drugs in the NLEM are scheduled drugs that are under price control by the central government. The drugs in the NLEM are scheduled drugs that are under price control by the central government.
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Neetu Chandra Sharma
  • Sep 14, 2022,
  • Updated Sep 14, 2022 11:24 PM IST

Pharma majors GSK and Sanofi may have a negative impact on their revenues after the central government has included drugs manufactured by these companies into the updated national list of essential medicines (NLEM). 

The drugs in the NLEM are scheduled drugs that are under price control by the central government.  While the NLEM portfolio constitutes 17 per cent of overall Indian Pharma Market (IPM) sales, the contribution is in the 7-44 per cent range for the top 25 companies.

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Amikacin, Cefuroxime, Insulin Glargine, Itraconazole, Mupirocin, and Teneligliptin each have annual sales of more than Rs 3 billion. The new list has added some anti-infectives such as Ivermectin, Mupirocin, and Nicotine Replacement Therapy, while drugs like Ranitidine and Sucralfate used to treat stomach ulcers, white petrolatum to treat dry skin, Atenolol and Methyldopa for treating high blood pressure have been deleted from the revised list. Ranitidine is a commonly used antacid.   “In our view, Ranitidine is a noteworthy product that has been excluded from the revised list. It has annual sales of more than Rs 6 billion with the majority of the market share secured by Cadila (Aciloc) and JB Chemicals (Rantac). Post exclusion from the list, these products are eligible for a maximum price hike of 10% on the selling price every year. Hence, JB Chemicals (Rantac is around 11% of its sales) would positively benefit,” said Bafna and John.   Union health minister Mansukh Mandaviya said that several antibiotics, vaccines, anti-cancer drugs, and many other important drugs will become more affordable and reduce patients’ out-of-pocket expenditure. Interestingly, NLEM 2022 also included patented drugs like bedaquiline and delamanid (anti-TB), dolutegravir (anti-HIV), and daclatasvir (Hepatitis C). Pharmaceutical associations have raised concern over the implication of including patented drugs on the list.  “NLEM includes four patented medicines for which companies have had robust access mechanism in place for India. OPPI is concerned with this inclusion of the four patented drugs and the implication it has on value for innovation,” said Vivek Sehgal, Director General, Organisation of Pharmaceutical Producers of India (OPPI). 

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“For the industry to be able to continue to make and supply the medicines from the NLEM 2015, the government should ensure that inflation is taken into account while fixing the ceiling price, this will enable the pharmaceutical industry to continue on its growth trajectory,” he said.    The central government on Tuesday added at least 34 drugs to the National List of Essential Medicines (NLEM) 2022 and dropped as many as 26 from the previous list. The NLEM 2022 contains a total of 384 drugs in comparison to 376 in NLEM 2015. The NLEM 2022 comprises 384 drugs across 27 categories

Pharma majors GSK and Sanofi may have a negative impact on their revenues after the central government has included drugs manufactured by these companies into the updated national list of essential medicines (NLEM). 

The drugs in the NLEM are scheduled drugs that are under price control by the central government.  While the NLEM portfolio constitutes 17 per cent of overall Indian Pharma Market (IPM) sales, the contribution is in the 7-44 per cent range for the top 25 companies.

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Amikacin, Cefuroxime, Insulin Glargine, Itraconazole, Mupirocin, and Teneligliptin each have annual sales of more than Rs 3 billion. The new list has added some anti-infectives such as Ivermectin, Mupirocin, and Nicotine Replacement Therapy, while drugs like Ranitidine and Sucralfate used to treat stomach ulcers, white petrolatum to treat dry skin, Atenolol and Methyldopa for treating high blood pressure have been deleted from the revised list. Ranitidine is a commonly used antacid.   “In our view, Ranitidine is a noteworthy product that has been excluded from the revised list. It has annual sales of more than Rs 6 billion with the majority of the market share secured by Cadila (Aciloc) and JB Chemicals (Rantac). Post exclusion from the list, these products are eligible for a maximum price hike of 10% on the selling price every year. Hence, JB Chemicals (Rantac is around 11% of its sales) would positively benefit,” said Bafna and John.   Union health minister Mansukh Mandaviya said that several antibiotics, vaccines, anti-cancer drugs, and many other important drugs will become more affordable and reduce patients’ out-of-pocket expenditure. Interestingly, NLEM 2022 also included patented drugs like bedaquiline and delamanid (anti-TB), dolutegravir (anti-HIV), and daclatasvir (Hepatitis C). Pharmaceutical associations have raised concern over the implication of including patented drugs on the list.  “NLEM includes four patented medicines for which companies have had robust access mechanism in place for India. OPPI is concerned with this inclusion of the four patented drugs and the implication it has on value for innovation,” said Vivek Sehgal, Director General, Organisation of Pharmaceutical Producers of India (OPPI). 

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“For the industry to be able to continue to make and supply the medicines from the NLEM 2015, the government should ensure that inflation is taken into account while fixing the ceiling price, this will enable the pharmaceutical industry to continue on its growth trajectory,” he said.    The central government on Tuesday added at least 34 drugs to the National List of Essential Medicines (NLEM) 2022 and dropped as many as 26 from the previous list. The NLEM 2022 contains a total of 384 drugs in comparison to 376 in NLEM 2015. The NLEM 2022 comprises 384 drugs across 27 categories

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