Findings and Conclusion Study Report of Pharmaceutical Manufacturing Industry in Nepal 2077

Background:

The historical event of the development of pharmacy was started during ancient Lichchhavi ruler Amshu Berma date back to 605-620 AD when a Ayurvedic hospital was established. In 1641- 1674 AD, King Pratap Malla started ayurvedic medicine production unit in the royal place. Modern allopathic medicines were introduced in Nepal in 1816 AD after Suguali Treaty and establishment of British residency in Nepal. Allopathic medicine manufacturing was started in 1969 in private sector and a government undertaking Royal Drug Limited was established in 1972.

Government of Nepal established Department of Drug Administration (DDA) in 1979 A.D (2036/07/01 B.S.) erstwhile under Ministry of forest & soil conservation and went under Ministry of Health and population after Poush, 2041 B.S. DDA is one of the three departments under Ministry of Health & Population.

At present situation there are 62 pharmaceutical industries manufacturing human related medicines, 8 pharmaceutical industries manufacturing medicines for animals and 73Ayurvedic medicine manufacturing industries. There are 390 foreign pharmaceutical industries which are supplying medicines through importers in Nepal. While analyzing data of domestic production and import of pharmaceutical products; it has been observed that market share of domestic production is 46%, medicine from India is 52% and other countries medicine is 2%. Specifically, vaccines, biotechnological products and modern technology related medicines; used for Anti-cancer, ART, critical care etc. are imported.

There were 359 medicines listed in National List of Essential Medicines in 2016. The medicines added in the Anti-tubercular and Antiretroviral groups are added to match with the National TB program and HIV AIDS Control Program of Government of Nepal.

Findings and Conclusion Study Report of Pharmaceutical Manufacturing Industry in Nepal 2077

There are 103 allopathic pharmaceutical industries registered in DDA, out of which only 66 industries are in operation. Four industries have stopped their production due to technical reason. (Manoj Chemical Works, Denium Laboratories Pvt. Ltd., Lomus Parenteral and Formulations Pvt. Ltd. and Unique Pharmaceuticals Pvt. Ltd.) Remaining 33 industries though registered have not yet received license for sales and marketing.

Annual capacity of tablets production from 66 industries is 2.06 billion, for capsules production from 60 industries is 1.87 billion, for liquid from 45 industries is 4.5 billion, for ointment from 40 industries is 0.15 billion, for powder from 20 industries (Dry syrup) is 0.03 billion and other (Eye/Ear drop) from 5 industries is 0.0037 billion units.
Capacity utilization of Nepalese running pharmaceutical industries for Tablet manufacturing is 55%, for capsules is 45%, for Liquid is 35%, for Ointment is 50%, for Powder is 40% and for Other (Eye/Ear) is 30%.
The five-years future demand of pharmaceutical products will be increased by 5% to 9% from 2077/78 to 2081/82 and average annual increment will be 7%.
The total demand electricity is about 10 MW, out of which NEA has supplied 8 MW and 2 MW energy is supplied from other sources like Diesel and Solar.
The direct employment generated from Pharmaceutical Industries is about 20 thousand. The percent composition of administrative, technical /skilled, non-skilled and others are 10, 30, 30 and 30 respectively.
Total investment in Pharmaceutical Industries is about 35 billion of 66 running industries.
The raw materials i.e. active and excipient imported from India is 80%, from china is 15% and from other countries is 5%.
About 90% (59) Industries are large scale and 10% are Medium scale. All industries have internal investment.
Market distribution system of pharmaceutical products are through Dealer (Stockiest) and few from tender also.
Most of the Pharmaceutical Industries have semi-auto production process and machineries are purchased mostly from India. Filling equipment are automatic.
Out of 66 operating industries, 36 industries are GMP certified from WHO and/or National Guidelines (DDA) and 10 are in process of getting GMP,
Only 10 industries are certified with management system like ISO 9001 and ISO 14001.
The import value of pharmaceutical products in last five years was highest in the fiscal year 2073/74 i.e. 30.11 billion rupees and lowest in the year 2075/76 i.e. 24.13 billion rupees.
According to APPON, import status and capacity utilization of the running industries, 55 products/molecules are towards self-reliant in Nepal. The average market consumption of 55 products by national industries is 72.88%