Whenever Nepal faces a natural calamity, such as floods or landslides, borders are often closed. This, coupled with calamities in neighbouring countries that disrupt exports to Nepal, frequently underscores the critical need for self-sufficiency in the field of medicine.
For years, Nepal’s pharmaceutical market has been dominated by medicines from neighbouring countries like India and Bangladesh. The fact that these countries do not allow a single drug from Nepal to enter their markets raises concerns and suggests a need for greater independence, even if motivated by a degree of economic jealousy.
Nepal, with a 50-year history of medicine production, is steadily advancing towards the highest levels of technological development. The quality of our pharmaceutical industry, which has consistently adhered to World Health Organisation production standards, is now recognised globally. Exports have commenced to several countries, including Congo, Myanmar, the Philippines and Vietnam, with further expansion anticipated in other African and Asian markets.
However, the reluctance of India and Bangladesh to grant Nepal market access for its pharmaceutical products while seeking to export freely to Nepal undermines the foundation of our bilateral relations.
Conversely, nearly all Indian companies have a presence in the Nepali market, while not permitting a single Nepali company entry. Does this reflect a balanced and equitable bilateral relationship?
Key Parameters for Medicine Quality:
1. Authenticity: Use of genuine raw materials adhering to Pharmacopeia standards.
2. Good Manufacturing Practices (GMP): Compliance with WHO guidelines for manufacturing processes.
3. Air and Water Quality: Maintaining high standards of air and water quality during production.
4. Pharmacopeial Methods: Adherence to established testing methods outlined in pharmacopeias (USP, BP, IP, JP, etc.).
5. Experienced Professionals: Employment of skilled and experienced technical personnel.
6. Area Cleanliness: Maintaining a clean and hygienic production environment.
7. Storage and Dispensing: Proper storage and dispensing practices to ensure product integrity.
8. Quality Testing: Rigorous quality control measures, including pre-production, in-process, and post-production testing.
9. Other Relevant Parameters
In recent years, the pharmaceutical industry in Nepal has prioritised the enhancement of technical standards to ensure the production of high-quality drugs. The regulatory department of the Nepali government oversees this process through rigorous guidelines and supervision, including both document validation and on-site audits. A multi-tiered inspection system is in place, encompassing reviews during research and development (R&D), production licensing, and marketing authorisation. Additionally, unannounced inspections are now conducted to further strengthen regulatory oversight.
Nepali pharmaceutical manufacturing processes adhere to stringent batch manufacturing protocols with comprehensive documentation. Production primarily focuses on pharmacopeia-grade products, adhering to established guidelines. Pharmaceutical plants are equipped with essential departments, including R&D, Quality Control, Microbiology, Production, Quality Assurance, primary and secondary storage, and maintenance. Regular knowledge-upgradation sessions are conducted within Nepali pharmaceutical industries to ensure adherence to standard operating procedures (SOPs). Furthermore, government agencies and the Association of Pharmaceutical Producers of Nepal organise various workshops to facilitate continuous learning and improvement.
Our primary focus should be on restricting imports in areas where we have achieved self-sufficiency, while simultaneously encouraging stakeholders to excel in sectors where we currently lag.
The Indian government actively promotes private sector exports through incentives such as expense reimbursement. Recently, from December 20-22, 2024, the Indian Pharma & Health Expo was held in Kathmandu with the support of the Indian government. Notably, most exhibitors were members of the Federation of Indian Chambers of Commerce and Industry (FICCI), and their expenses were partially subsidised by the Indian government.
Similarly, the Nepali government should demonstrate a strong commitment to promoting the export of Nepali medicines to the global market. Our products possess the quality to compete effectively with those of our neighbours. With the implementation of high-tech engineering in our production facilities, we have the capacity to meet both domestic demand and export requirements.
Nepali products enjoy higher acceptance rates compared to foreign counterparts, a significant validation of their quality. Data serves as the cornerstone for information, quantification and process validation. However, this year’s analysis reveals a different set of results in the top 10 product segments.
In this scenario, we must acknowledge the need to develop expertise in other market segments to expand our product portfolio and market share. As a sovereign nation, Nepal has the inherent right to determine its market strategy both domestically and internationally. When sufficient quantities of high-quality products are manufactured by Nepali industries, there should be no hesitation in declaring self-sufficiency. Our neighbours should also recognise that they benefit significantly from the Nepali market in terms of raw materials, machinery and other related sectors. The question arises: What if Nepal were granted the autonomy to determine its domestic market and prioritise self-sufficiency in medicine?
(Ojha is Executive Director of Ideal Pharmaceuticals. He can be reached at Ojha.idealpharma@gmail.com)
