Drugdu.com expert's response:

There are significant differences between domestically produced generic targeted drugs and Indian-produced generic targeted drugs in terms of research and development foundations, production standards, market regulation, pricing strategies, quality risks, and international recognition. A detailed analysis is as follows:

I. Research and Development Foundations and Adaptability to Indications

Domestically Produced Generic Drugs: These are typically developed based on extensive domestic clinical data and patient needs, enabling them to more precisely adapt to the genetic characteristics, disease spectra, and medication habits of Chinese patients. For example, domestically produced Gefitinib (Iressa) was optimized during the research and development phase to target the high-incidence mutation types in Chinese patients with non-small cell lung cancer, ensuring efficacy and safety.
Indian-Produced Generic Drugs: These rely on global research and development experience, particularly excelling in the field of biosimilars. However, they may not fully consider the specific needs of Chinese patients. For instance, Indian-produced Gefitinib, although widely used in international markets, may not be as precise as domestically produced versions in terms of dosage adjustments or side effect management for Chinese patients.

II. Production Standards and Quality Control

Domestically Produced Generic Drugs: These must strictly adhere to the Good Manufacturing Practice (GMP) regulations set by the China National Medical Products Administration (NMPA), undergoing multiple rounds of audits from raw material procurement and production processes to finished product inspections. For example, domestically produced generic Chidamide tablets must complete bioequivalence tests to prove their efficacy and absorption rates are consistent with those of the original drug, and their production facilities must pass three unannounced inspections.
Indian-Produced Generic Drugs: These must comply with the standards set by the Indian Central Drugs Standard Control Organization (CDSCO), with some companies also obtaining certification from the FDA or EMA. However, there is a phenomenon of inconsistent quality in the Indian market. For instance, a 2023 inspection revealed that 15% of Sildenafil generic drugs had actual efficacy contents ranging from only 60% to 80% of the labeled amounts, with some companies even incorporating other ingredients, increasing cardiovascular risks.

III. Market Regulation and Compliance

Domestically Produced Generic Drugs: China has recently strengthened the consistency evaluation of generic drugs, requiring them to be equivalent to the original drugs in terms of quality and efficacy. Drugs that fail to pass the evaluation will be eliminated, ensuring the compliance of products circulating in the market.
Indian-Produced Generic Drugs: India circumvents patent restrictions by exploiting the "process patent" loophole (which only protects production steps rather than drug components) and relaxes ethical reviews for clinical trials, enabling low-cost and rapid market entry. While this approach reduces prices, it may compromise certain safety and ethical standards.

IV. Pricing Strategies and Patient Burden

Domestically Produced Generic Drugs: Pricing takes into account the affordability of domestic patients, typically ranging from one-third to one-half of the price of the original drugs. For example, domestically produced Gefitinib (1,680 yuan per box) is 30% cheaper than the original drug (2,350 yuan per box), with some products covered by medical insurance reimbursement.
Indian-Produced Generic Drugs: These are more competitively priced due to lower production costs and the absence of patent fees. For instance, Indian-produced Gefitinib, after being distributed to Chinese patients through intermediaries, costs approximately 700-800 yuan per box, only one-third of the price of the original drug.

V. Quality Risks and Long-Term Efficacy

Domestically Produced Generic Drugs: Drugs that pass the consistency evaluation demonstrate high consistency with the original drugs in terms of efficacy and safety. For example, domestically produced generic Metformin tablets have a dissolution profile that overlaps with the original drug by 98%, alleviating patient concerns about "ineffectiveness."
Indian-Produced Generic Drugs: Some smaller manufacturers may compromise on quality to reduce costs, leading to unstable efficacy or increased side effects. For instance, Indian-produced generic Sotorasib, although low-priced, requires patients to bear potential quality risks.

VI. International Recognition and Market Layout

Domestically Produced Generic Drugs: International recognition is gradually increasing, but they remain less competitive in the European and American markets due to historical brand image limitations. In recent years, they have expanded into developing countries through the "Belt and Road" initiative.
Indian-Produced Generic Drugs: Known as the "world's pharmacy," these products are exported to over 200 countries globally, particularly dominating markets in Africa and Latin America. However, the European and American markets still harbor doubts about their quality, with some drugs requiring local partnerships (such as Gilead's authorization for Indian production of hepatitis C drugs) to enter.