China supplied about USD 3.2 billion of the USD 4.35 billion of active pharmaceutical ingredients (APIs) that India imported in fiscal year 2024-25. That is 73.7% of the import value. [1] In the same year, Indian pharmaceutical exports reached USD 30.5 billion and went to 191 countries. [2]
These two facts frame a question that Indian policymakers, investors and company executives now ask in public. Can Indian pharma gain real bargaining power with China, or does it stay a customer? We tested the question with government data, company filings and regulatory records. We also ran five calculations of our own. The text labels each one as analysis.
The answer has two parts. On API supply, India has not changed its position yet. In the other levers we define below (market access in China, licensing of Chinese drugs, and patent and regulatory rules), Indian companies have built positions that are small but documented.
The Short Answer: Can Indian Pharma Gain Leverage Over China?
Not as a supplier, and not yet at scale. India still buys most of its imported API from China. [1] India has gained a documented but small position as a buyer of Chinese innovation, as a bidder in China’s volume-based procurement, and as a generic competitor in markets where Chinese rivals face delays.
What the evidence supports
Indian companies won supply contracts in China’s latest national procurement round for dapagliflozin, oxcarbazepine and olaparib. [3]
Indian companies licensed at least five Chinese drugs between May 2023 and September 2025. [4][5][6][7]
India’s semaglutide patent expired on March 20, 2026, and generics launched. [8] A Chinese generic faces a data-protection hold until April 2027. [9]
India’s goods exports to China rose 36.66% in fiscal 2025-26 to USD 19.47 billion. [10]
What the evidence does not support
A fall in China’s share of Indian API imports. The available data show a rise or a plateau. [11][1]
Large revenue from China. No source we reviewed gives Indian pharma sales in China, and the procurement contracts have no disclosed price or volume. [3]
Proof that India’s production-linked incentives have replaced Chinese imports at scale. Our calculation below shows a small ratio.
A pharma-specific export figure for India-to-China trade. The sources we reviewed give only all-goods totals. [10]
The Nine Findings That Matter
China supplied 73.7% of India’s fiscal 2024-25 API imports, about USD 3.2 billion of USD 4.35 billion. [1]
Bulk drug imports rose 56.1% from INR 24,172 crore in fiscal 2019-20 to INR 37,722 crore in fiscal 2023-24. China-origin imports rose by more than 64% over the same period. (Analysis based on data in [11].)
China supplied 86.1% of India’s antibiotic API imports in 2025, according to NITI Aayog’s Trade Watch report as covered by the press. [12]
Cumulative bulk drug PLI sales of INR 2,313.16 crore equal 8.6% of one year of China-origin bulk drug imports. (Analysis based on [2] and [11].)
Chinese companies signed 157 out-licensing deals worth USD 135.7 billion in 2025. That is an average of USD 864 million per deal. (The average is analysis based on [13].)
Glenmark’s USD 18 million upfront payment for SHR-A1811 is 1.6% of the deal’s headline value. The same ratio is 4.2% for GSK-Hengrui and 20.7% for Pfizer-3SBio. (Analysis based on [7] and [13].)
India’s fiscal 2025-26 imports from China were 6.8 times its exports to China. (Analysis based on [10].)
If India replaced 50% of Chinese API value with domestic output, China would still supply about 58% of imported API value. (Scenario analysis based on [1].)
Indian generic semaglutide launched about 12 months or more before the earliest expected Chinese generic. (Analysis based on [8] and [9].)
How We Built the Numbers: Methodology and Limits
What data we used and what period it covers
We used four types of source. The first type is government statements and parliamentary replies on API imports, incentive schemes and trade. The second type is research summaries from the Observer Research Foundation and from NITI Aayog’s Trade Watch as reported by the press. The third type is company filings and announcements for licensing deals. The fourth type is law firm and news summaries of regulation in the United States and China.
The period runs from 1990 to October 19, 2026. Most figures cover fiscal years 2019-20 to 2025-26. India’s fiscal year runs from April to March.
How we selected records and handled duplicates
We counted a licensing deal when a company filing or a news report named both parties, the product and the date. We excluded deals with unnamed parties. When two sources gave the same figure, we used the one closer to the primary document. When sources gave different figures, we show both.
How we calculated the derived figures
Growth rate: later value divided by earlier value, minus 1.
Share: China-origin value divided by total import value for the same period.
Upfront-to-headline ratio: upfront payment divided by upfront plus stated milestones, or by the stated total when the source gives one.
PLI-to-import ratio: cumulative PLI sales divided by one year of China-origin imports. This ratio overstates progress, and we explain why below.
Why do published API import figures disagree?
Published API totals differ by a factor of more than five, because each source defines its product basket in a different way. The table lists the figures we found.
Source
Period
Reported figure
Scope note
Rajya Sabha answer, as summarized by Policy Edge [1]
FY2024-25
Total API imports about USD 4.35 billion; China about USD 3.2 billion (73.7%)
200 categories
NITI Aayog Trade Watch, as reported [12]
2025
Total API imports USD 7.4 billion; top five categories USD 6.2 billion (about 84%)
China share 65% to 86% across leading categories
Observer Research Foundation, official bulk drug data [11]
FY2019-20 to FY2023-24
Bulk drug imports INR 24,172 crore to INR 37,722 crore; from China INR 16,443 crore to over INR 27,000 crore
Share above 70%
Observer Research Foundation, UN Comtrade (HS 29) [11]
2024
Organic chemical imports almost USD 26.0 billion; from China more than USD 11.1 billion
HS 29 is a proxy, not an exact API match
We could not reconcile the USD 4.35 billion and USD 7.4 billion totals from the public summaries. Neither summary lists its product codes.
Definitions: API, KSM and HS 29
An API is the component of a medicine that produces its intended effect. A key starting material (KSM) is a chemical that enters the API synthesis early and becomes part of the API structure. HS 29 is the customs chapter for organic chemicals. It includes chemicals that have no medical use.
Rounding and period mismatches
ORF reports China-origin bulk drug imports as “over” INR 27,000 crore. We use 27,000 as a lower bound, so our fiscal 2023-24 share of 71.6% is a minimum. We did not convert rupees to dollars, because the sources use both currencies for different years. One crore equals 10 million.
Limits of this analysis
We read several government figures through press and research summaries, not through the original tables. The reference list shows which. No source gave Indian pharmaceutical sales in China. Procurement contract terms and several licensing terms are undisclosed.
How Dependent Is India on China for APIs?
What share of Indian API imports comes from China?
China supplied 73.7% of India’s fiscal 2024-25 API import value. The European Union supplied 13.6%, Singapore 2.5% and the United States 1.9%. [1]
Official bulk drug data show a long plateau above two-thirds. China supplied INR 16,443 crore of INR 24,172 crore in fiscal 2019-20. That is 68.0%. (Analysis based on [11].) By fiscal 2023-24 the share was at least 71.6%. (Analysis based on [11].)
The volume trend points the same way. API imports from China grew by around 30% in volume between 2021 and 2024, according to a Lok Sabha reply by Minister of State Anupriya Patel on July 25, 2025. [14]
Which API product classes are most exposed to China?
Two product classes make up about 58% of the API import basket in the NITI Aayog report. China supplies more than three-quarters of each class. [12]
Product class
Import value (2025)
Share of API imports
China’s share of the class
Source
Nitrogen heterocyclic compounds
USD 2.3 billion
31.9%
76.4%
[12]
Antibiotics
USD 1.9 billion
26.1%
86.1%
[12]
Amino compounds
Not stated
11.5%
Not stated
[12]
Antibiotics: penicillin G, 6-APA and amoxicillin
ORF puts China’s share of Indian antibiotic imports at 87%. [11] The government reacted in early 2026. It set a minimum import price on penicillin G and its salts, 6-APA and amoxicillin for one year. The measure aims to curb low-cost imports, especially from China. [15]
Nitrogen heterocyclic compounds
This class is the largest in the basket by value. The coverage we reviewed does not name the molecules in the class, so we cannot map it to specific medicines. [12]
Why is Chinese API cheaper than Indian API?
The NITI Aayog report estimates that Chinese APIs cost 35% to 40% less than domestic alternatives. The report says this gap has contributed to some domestic plant closures. [12]
The sector matters to India’s economy. NITI Aayog says pharma contributes more than 1.7% of GDP and 7.2% of manufacturing gross value added. It supports about 2.7 million livelihoods. [12]
Timeline: how did the dependence form?
1990-91: China supplied under 1% of India’s bulk drug imports. [11]
Mid-1990s: China’s share exceeded 20%. [11]
2020: China supplied roughly two-thirds of API and intermediate imports, as cited by ORF from the work of Sudip Chaudhuri. [11]
2001 to 2024: India’s HS 29 imports from China grew from about USD 0.29 billion to more than USD 11.1 billion. [11]
Is the PLI Scheme Replacing Chinese Imports?
India runs two production-linked incentive (PLI) schemes that touch API supply. The bulk drug scheme was approved in 2020. The broader pharmaceutical scheme was approved in 2021. [16] Both beat their investment targets. Neither has yet cut China’s import share in the data we found.
PLI results: pharmaceuticals and bulk drugs compared
Scheme
Investment commitment
Actual investment
Actual vs. commitment (analysis)
Cumulative sales
Source
Pharmaceutical PLI (as of March 2026 reply)
INR 17,275 crore
INR 41,943 crore
2.43 times
INR 3,35,036 crore, of which INR 2,15,248 crore exports
[16]
Bulk drug PLI (investment from March 2026 reply)
INR 4,329.95 crore
INR 4,814 crore
1.11 times
INR 2,313.16 crore as of September 2025, of which INR 508.12 crore exports
[16][2]
The sales figures come from different reporting dates. The bulk drug sales figure is older than the investment figure beside it.
What did the bulk drug PLI scheme build?
The scheme originally envisaged 82,270 metric tonnes per annum of capacity for 41 products. Committed capacity is 91,077 metric tonnes per annum for 33 products. [16] Six new units opened in Visakhapatnam, Andhra Pradesh. [16]
As of September 2025, the scheme had established 55,100 metric tonnes per year of capacity for 26 critical APIs and KSMs. It employed 4,929 people. [2]
How many bulk drug parks exist, and what do they cost?
The government approved three bulk drug parks, in Andhra Pradesh, Gujarat and Himachal Pradesh. The total project cost exceeded INR 6,306.68 crore as of February 2026. Central assistance is INR 1,000 crore per park, within a budget outlay of INR 3,000 crore. [2]
Central assistance covers 47.6% of the stated project cost. (Analysis based on [2].)
PLI sales versus China-origin imports: the calculation
The ratio
Cumulative bulk drug PLI sales of INR 2,313.16 crore equal 8.6% of one year of China-origin bulk drug imports, which ORF reports as more than INR 27,000 crore in fiscal 2023-24. (Analysis based on [2] and [11].)
The government says PLI schemes for pharmaceuticals and bulk drugs avoided imports worth INR 3,591 crore of APIs, KSMs and drug intermediates. [2] That equals 13.3% of the same one-year import base. (Analysis based on [2] and [11].)
Why the ratio overstates progress
The ratio compares a multi-year sales total with a single year of imports. It also mixes reporting dates. Exports are 22.0% of cumulative bulk drug PLI sales (INR 508.12 crore of INR 2,313.16 crore), so those sales did not replace imports at home. (Analysis based on [2].) Even with these flaws, the ratio shows the scale gap between the incentive output and the import base.
Why did India set a minimum import price on penicillin G?
The government imposed a one-year minimum import price on penicillin G and its salts, 6-APA and amoxicillin. Exemptions cover 100% export-oriented units, special economic zone units and imports under advance authorisation. [15] The measure followed an earlier minimum import price on sulphadiazine in November. [15]
The coverage cites about 70% Chinese content in the raw materials that India’s pharma industry uses. It values those raw materials at USD 10 billion to USD 12 billion. [15]
Scenario Analysis: What If India Replaces 10%, 25% or 50% of Chinese API?
Assumptions
The baseline is fiscal 2024-25. Total API imports are USD 4.35 billion and China’s share is 73.7%. China-origin imports are therefore about USD 3.21 billion. [1] We assume India replaces a fixed share of China-origin value with domestic output. We assume total demand stays constant and imports from other countries do not change.
Results
Scenario (analysis)
China-origin value replaced
China-origin imports left
Total imports left
China’s share of imports
Baseline
0
USD 3.21 billion
USD 4.35 billion
73.7%
10% replaced
USD 0.32 billion
USD 2.89 billion
USD 4.03 billion
71.6%
25% replaced
USD 0.80 billion
USD 2.40 billion
USD 3.55 billion
67.8%
50% replaced
USD 1.60 billion
USD 1.60 billion
USD 2.75 billion
58.4%
Replacing half of all Chinese API value would still leave China as the source of more than half of imported API. The share falls slowly because the base is so concentrated.
What the scenarios leave out
The model treats Indian output as free of Chinese inputs. Real plants may buy their own intermediates abroad. The public data we reviewed does not measure this. The model also ignores price, and the price gap is 35% to 40%. [12]
Four Levers of Influence: An Original Framework
We define leverage as the ability to change a counterparty’s terms or choices. We split it into four levers. This is our own framework, not an industry standard. The evidence ratings are our judgment based on the sources cited in this article.
Lever
What it means
Key evidence
Evidence rating (analysis)
Supplier lever
India supplies something China needs and cannot easily replace
None found. India is the buyer in API trade. [1]
Weak
Customer lever
India buys or sells at a scale that changes Chinese behavior
All-goods exports to China up 36.66% to USD 19.47 billion; pharma-specific figure not found. [10]
Emerging
Innovation-channel lever
Chinese developers choose Indian firms as commercial partners
At least five named deals, 2023 to 2025. [4][5][6][7]
Moderate
Rule lever
Patent, data-protection and trade rules shift timing in India’s favor
Semaglutide timing gap; US policy exempts generics for now. [8][9][17]
Conditional
Supplier lever: why India has little leverage
India imports 73.7% of its API by value from one country. [1] A buyer in that position does not have supplier leverage. The minimum import price is a defensive tool, not a source of influence. [15]
Customer lever: how large is India’s pull on China?
China overtook the United States as India’s largest trading partner in fiscal 2025-26. Bilateral trade reached USD 151.1 billion. Indian exports to China were USD 19.47 billion and imports from China were USD 131.63 billion. [10]
India bought 6.8 dollars of Chinese goods for each dollar it sold. (Analysis based on [10].) The ratio covers all goods. The sources we reviewed do not break out pharmaceuticals.
Innovation-channel lever: India as a commercial partner
This lever shows the best documented progress. The deals are covered in detail below.
Rule lever: patents, data protection and trade policy
Timing rules set when generics can enter. The semaglutide case below shows a gap of about a year between India and China. The lever is conditional, because it depends on rules that governments can change.
Can Indian Generics Win in China? Volume-Based Procurement Explained
What is China’s volume-based procurement?
Volume-based procurement (VBP) aggregates the demand of public hospitals and negotiates lower prices with suppliers. [3] The tenth national round ended with a record average price reduction above 70%. [18]
Which Indian companies won in the latest round?
Cipla, Natco Pharma, Hetero Labs and Annora Pharma were selected for supply. Hetero and Cipla won dapagliflozin in selected provinces. Annora won oxcarbazepine tablets. Natco won olaparib. [3]
Public hospital sales of dapagliflozin in China were RMB 5.35 billion in 2024, which is over USD 700 million. [3] The report gives no price or volume terms for any contract. It says experts expect thin margins. [3]
How big was the 11th round?
The 11th round covered 55 drugs across 14 therapeutic areas. [19] A total of 272 companies and 453 products were pre-qualified to bid. [3] The agency excluded 68 drugs that met volume conditions. [18] It excluded enzalutamide because of IP disputes. [19]
The anti-involution rules
The lowest price no longer wins automatically. The lowest bidder must explain its price against production cost. [19] Bidders now need two years of manufacturing experience and a clean GMP record, applied at production-line level. [19][18]
Losing bidders can take part in up to 40% of the post-tender market. [19] Hospitals may report volumes by brand. [18]
What thin margins mean for Indian bidders
A market of more than USD 700 million is large. A 70% average price cut in the prior round shows how fast price falls. [3][18] The rule changes reduce the risk of a bid below cost. They do not remove price pressure.
What did India’s ambassador ask China to do?
On July 4, 2026, Ambassador Vikram Doraiswami spoke at the World Peace Forum organized by Tsinghua University in Beijing. He asked Chinese partners to help firms that make high-quality generic medicines enter the Chinese market. He described the arrangement as a “balance of advantage” for both countries. [10]
The request shows that India still seeks access. It does not show leverage.
Why Chinese Innovation Gives India a New Role: Licensing Deals
How big is China’s out-licensing wave?
Chinese drugmakers signed 157 cross-border licensing deals worth USD 135.7 billion in 2025. In 2024 the figures were 94 deals and USD 51.9 billion. The data come from PharmCube’s NextPharma database. [13]
Total value grew 2.6 times, and deal count grew 1.7 times. The average deal rose from USD 552 million to USD 864 million. (Analysis based on [13].) The ten largest Chinese companies accounted for 60% of the value. [13]
46% of new drug molecules that entered human trials in the first half of 2025 came from Chinese companies, up from about 17% a decade earlier (Goldman Sachs, December 17, 2025). [20]
Goldman Sachs also reports that China accounts for about half of global licensing deals by value and 26% by count. [20] Chinese biopharma drove about 70% of global antibody-drug conjugate (ADC) development over the past two and a half years. [20]
Which Indian companies license drugs from Chinese developers?
Date
Indian company
Chinese company
Product
Rights
Reported value
Source
May 8, 2023
Dr. Reddy’s
Shanghai Junshi Bio
Toripalimab (anti-PD-1)
Latin America, India, South Africa, with options for other countries
Up to USD 728 million
[4]
Oct. 2023
Dr. Reddy’s
Jiangsu Hengrui
Pyrotinib (oral breast cancer drug)
India, exclusive
Not disclosed
[5]
Feb. 6, 2025
Dr. Reddy’s
Henlius Biotech
HLX15 (daratumumab biosimilar)
US and 42 European countries
Not disclosed
[6]
Feb. 10, 2025
Intas
Bio-Thera Solutions
BAT2506 (golimumab biosimilar)
US, exclusive
Up to USD 165 million
[6]
Sept. 24, 2025
Glenmark Specialty
Hengrui Pharma
Trastuzumab rezetecan (SHR-A1811, HER2 ADC)
Worldwide, with listed exclusions
USD 18 million upfront; up to USD 1.093 billion in milestones
[7]
Glenmark and Hengrui: SHR-A1811
Glenmark Specialty holds exclusive rights to a next-generation HER2-targeting ADC. The license excludes mainland China, Hong Kong, Macao, Taiwan, the USA, Canada, Europe, Japan and ten Russia, Central Asia and Caucasus countries. Glenmark pays USD 18 million upfront, up to USD 1.093 billion in milestones, and royalties on net sales. [7]
Dr. Reddy’s: Junshi, Hengrui and Henlius
Dr. Reddy’s has three named deals with Chinese licensors in our sample. The toripalimab deal also gave Dr. Reddy’s a right of first negotiation on two other Junshi products. [4] The pyrotinib deal was the second overseas agreement Hengrui signed for that drug. [5]
Intas and Bio-Thera: BAT2506
BAT2506 completed global Phase III trials, and the European Medicines Agency accepted its marketing application. The deal gives Intas exclusive US rights. [6]
How does Glenmark’s upfront compare with Western licensing deals?
Glenmark’s upfront payment is the smallest share of headline value in our comparison. The table shows upfront payments as a share of upfront plus stated milestones, or of the stated total.
Deal
Licensee
Upfront
Headline value used
Upfront share (analysis)
Source
SHR-A1811
Glenmark
USD 18 million
USD 1.111 billion (upfront plus milestones)
1.6%
[7]
GSK and Hengrui
GSK
USD 500 million
About USD 12 billion
4.2%
[13]
Merck and Hengrui
Merck
USD 200 million
USD 1.97 billion (upfront plus milestones)
10.2%
[13]
Pfizer and 3SBio
Pfizer
USD 1.25 billion
USD 6.05 billion (upfront plus milestones)
20.7%
[13]
A low upfront share limits the cash that Glenmark puts at risk before approval. It also shows that the deals differ in territory and asset, so the ratio does not measure asset quality. Headline definitions vary by deal.
What do the territory splits show?
Three of the five deals (Junshi, Hengrui pyrotinib and Glenmark) give Indian companies rights in India or in markets outside the US, Europe, Japan and China. Two deals (Intas and Dr. Reddy’s with Henlius) give Indian companies US and European rights to biosimilars. [4][5][7][6] (The split is analysis.)
In the two biosimilar cases, Chinese developers chose Indian companies for US and European rights. That is a documented channel role. It is not the same as influence over China.
How large is the Indian share of China’s out-licensing?
We found three 2025 deals with Indian licensees: Dr. Reddy’s-Henlius, Intas-Bio-Thera and Glenmark-Hengrui. Against 157 total deals, three is about 1.9%. (Analysis based on [13], [6] and [7].) We do not know how many of the three PharmCube counts. Treat the figure as an order-of-magnitude check, not a measured share.
Semaglutide: India Versus China on Generic Entry
India: patent expiry on March 20, 2026
Indian companies can make and sell semaglutide without Novo Nordisk’s license since March 20, 2026. [8] Sun Pharma received approval in December 2025 for the brand Noveltreat. Dr. Reddy’s plans 12 million pens in year one. Natco’s vial starts at INR 1,290 per monthly dose. [8]
The coverage counts over 40 manufacturers and expects more than 50 brand names in India during 2026. Generic prices are expected at 50% to 60% below the innovator price at launch. [8]
China: data protection until April 2027
Ozempic has regulatory data protection in China until April 2027 under the China-Switzerland Free Trade Agreement, according to a Bloomberg report published on May 6, 2026. Hangzhou Jiuyuan Genetic Biopharmaceutical was the first Chinese company to apply for approval of a generic. It said in March that its review is suspended. [9]
Another source reports that key semaglutide patents expired in India, China and Canada in 2026. [21]
Item
India
China
Source
Key patent status
Expired March 20, 2026
Expired March 2026 (day not stated)
[8][9]
Regulatory data protection
Not reported as a barrier
Until April 2027
[9]
Generic status
Over 40 manufacturers; launches under way
First applicant’s review suspended
[8][9]
Export intent
Dr. Reddy’s targets 87 countries
Not reported
[8]
What does the timing gap mean?
The earliest expected Chinese generic comes about 12 months or more after the Indian launch. (Analysis based on [8] and [9].) In this case, a regulatory rule set the timing, not manufacturing capacity. No source we reviewed reports an Indian semaglutide approval in China. The gap helps Indian exporters in third markets. It does not give India control over China.
China’s Patent Linkage System: What It Means for Indian Generic Filers
How does China’s patent linkage system work?
China’s National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) released the implementing measures on July 4, 2021. Marketing authorization holders register drug and patent information on a platform. [22]
Chemical generics file one of four certification types. Type I states that no relevant patent is registered. Type II states that the patent expired, was declared invalid or is licensed. Type III states that the applicant will wait for expiry. Type IV states that the patent is invalid or does not cover the generic. [22]
The nine-month stay
After a Type IV certification, the patent owner can go to court or CNIPA within 45 days. A proceeding triggers a nine-month hold on generic approval. [22]
The 12-month exclusivity
The first successful challenger can receive up to 12 months of market exclusivity. The exclusivity cannot extend beyond the term of the challenged patent. [22]
Feature
China
United States (Hatch-Waxman)
Source
Stay on generic approval
9 months
30 months
[22]
Challenge window
45 days
45 days
[22]
First-challenger exclusivity
Up to 12 months
180 days
[22]
Certification types
4
4 (similar)
[22]
What does this mean for Indian ANDA filers?
A generic company that already files US Paragraph IV certifications knows the four-category structure, the 45-day window and the stay logic. China uses a similar design with a shorter stay and a longer exclusivity period. [22] (The reading for Indian filers is analysis.)
The shorter stay means a challenger reaches a decision window sooner. The longer exclusivity period raises the value of being first. The 2021 measures cover Chinese patents, so an Indian filer needs Chinese counsel and a Chinese manufacturing or import plan. We found no source that counts Indian filers under the Chinese system.
How Do US Policies Change India’s Position?
What does the BIOSECURE Act do?
The BIOSECURE Act is Section 851 of the Fiscal Year 2026 National Defense Authorization Act. President Trump signed it on December 18, 2025. [23] The Act names no companies. An entity becomes a “biotechnology company of concern” through the Department of Defense 1260H list or through designation by the Office of Management and Budget. [23]
The 1260H list includes BGI Group but not WuXi AppTec or WuXi Biologics. The 2024 bill named the WuXi companies. The enacted Act does not. [23] OMB must publish its list within one year of December 18, 2025. Contracts signed before an entity’s effective date are grandfathered for five years. [23]
Do US Section 232 tariffs cover generics?
Not for now. A proclamation dated April 2, 2026 applies a 100% duty to patented pharmaceuticals and related ingredients under Section 232. Generics, biosimilars and their ingredients are excluded, and the White House will reassess the exclusion in one year. [17]
Duties start on July 31, 2026 for companies on Annex III and on September 29, 2026 for all others. Firms with a most-favored-nation pricing agreement and an onshoring agreement pay zero through January 20, 2029. The European Union, Japan, South Korea and Switzerland pay 15%. [17]
What happens if the generic exemption ends?
The exemption ends only if the US changes the rule. We do not forecast that. The exposure is clear, however. The United States took about 38% of India’s pharmaceutical exports in 2024, measured on HS 30 finished products. [11]
These two US measures change who may supply US buyers and at what cost. They do not by themselves give India leverage over China. They raise the value of non-Chinese supply chains, which supports the case for domestic API capacity. (This reading is analysis.)
Can India Build an Innovation Base? Patents and Biopharma SHAKTI
What do the WIPO patent filing numbers show?
China’s patent office received 1.8 million applications in 2024, up 9%. The US office received 603,194. [24] India’s office filings grew 16.5% and origin filings grew 19.1%. Resident filers made up 60.1% of applications received in India. [24]
The growth rates are not comparable in size, because the bases differ. The WIPO text we reviewed does not give India’s absolute counts or pharma-specific counts.
What is Biopharma SHAKTI?
The Union Budget for 2026-27 proposes an outlay of INR 10,000 crore over five years for biologics and biosimilars. The plan includes over 1,000 accredited clinical trial sites and added capacity at the Central Drugs Standard Control Organisation. It also lists three new National Institutes of Pharmaceutical Education and Research and upgrades to seven existing ones. [25]
The document does not say that the scheme covers APIs or KSMs. Those fall under the PLI, bulk drug park and related schemes. [25]
How the scheme links to the licensing channel
Four of the five licensing deals in our table involve antibodies, ADCs or biosimilars: toripalimab, SHR-A1811, HLX15 and BAT2506. [4][7][6] Faster regulatory review and more trial sites in India could support that channel. (This link is analysis.)
Timeline: Key Events, 1990 to 2027
Date
Event
Status
Source
1990-91
China supplies under 1% of India’s bulk drug imports
Historical
[11]
2020
Bulk drug PLI scheme approved; China supplies about two-thirds of API imports
Historical
[16][11]
2021
Pharmaceutical PLI approved; China issues patent linkage measures (July 4)
Historical
[16][22]
May 8, 2023
Dr. Reddy’s licenses toripalimab from Junshi
Confirmed
[4]
Feb. 2025
Dr. Reddy’s-Henlius and Intas-Bio-Thera biosimilar deals
Confirmed
[6]
Sept. 24, 2025
Glenmark licenses SHR-A1811 from Hengrui
Confirmed
[7]
Nov. 2025
Cipla, Natco, Hetero and Annora selected in China’s VBP round
Confirmed
[3]
Dec. 18, 2025
BIOSECURE Act signed
Confirmed
[23]
Early 2026
Minimum import price on penicillin G, 6-APA, amoxicillin
In force for one year
[15]
Mar. 20, 2026
India semaglutide patent expires
Confirmed
[8]
Apr. 2, 2026
Section 232 proclamation on patented pharmaceuticals
Confirmed
[17]
July 4, 2026
India’s ambassador asks China to help Indian generic makers enter its market
Confirmed
[10]
By Dec. 18, 2026
OMB must publish BIOSECURE list
Scheduled by statute
[23]
Apr. 2027
China data protection for Ozempic ends
Reported expectation
[9]
What This Means for Indian Generic Manufacturers
Treat China as a market with thin margins and strict quality rules. The 11th VBP round requires two years of manufacturing experience and a clean GMP record at production-line level. [19] Companies that cannot meet that bar will not qualify.
Plan API sourcing for a world in which the import share changes slowly. Even a 25% substitution would leave China at about 68% of import value. (Scenario analysis; see above.)
What This Means for Global Brand Companies and Licensors
Indian companies appear as licensees for emerging markets and for US and European biosimilars. [7][6] A licensor with ex-China rights can compare Indian partners on territory fit, regulatory record and milestone structure.
Check each asset’s patent and data-protection calendar by country. The semaglutide case shows that a country’s rules can move a launch by a year. [9]
What This Means for Supply Chain and Procurement Teams
Map exposure by product class, not by country total. Antibiotic APIs show the highest China share in the NITI Aayog data, at 86.1%. [12] Watch the minimum import price and its expiry date. [15]
How to Track the Patent Calendar Behind These Moves
Every channel in this article depends on dates: patent expiry, exclusivity end, stay periods and data protection. DrugPatentWatch tracks drug patents, exclusivities and litigation records. Analysts can use it to build a country-by-country calendar for a molecule such as semaglutide.
Use it as a map to the primary documents, not as a replacement. Confirm each date against the national patent office, the regulator and the court record.
Key Takeaways
China supplied 73.7% of India’s fiscal 2024-25 API imports, about USD 3.2 billion of USD 4.35 billion. [1]
Antibiotic APIs are the most exposed class, at 86.1% China-origin. [12]
Bulk drug PLI sales equal about 8.6% of one year of China-origin imports. This ratio overstates progress. (Analysis.)
Replacing half of Chinese API value would leave China at about 58% of imports. (Scenario analysis.)
Four Indian companies won China VBP supply slots, and at least five Indian licensing deals with Chinese developers are documented. [3][7][6][4][5]
Glenmark’s SHR-A1811 upfront is 1.6% of headline value, the lowest share in our comparison. (Analysis.)
India’s generic semaglutide launch precedes the earliest expected Chinese generic by about a year or more. (Analysis.)
US generic exemptions from Section 232 duties are under a one-year review. [17]
The evidence supports narrow leverage in licensing, market access and rule timing. It does not support leverage in API supply.
FAQ
How important is pharma to the Indian economy?
NITI Aayog says pharma contributes more than 1.7% of GDP and 7.2% of manufacturing gross value added. It supports about 2.7 million livelihoods. [12]
How did India’s trade with China change in fiscal 2025-26?
Exports rose 36.66% to USD 19.47 billion, and imports rose 16% to USD 131.63 billion. The trade deficit set a record, reported as USD 112.16 billion or USD 112.6 billion, against USD 99.2 billion a year earlier. [10]
How concentrated is China’s out-licensing?
Fifty-four Chinese drugmakers took part in 2025 deals. The top ten accounted for 60% of total value. Jiangsu Hengrui led with USD 16.7 billion. [13]
Which drugs did China’s 11th VBP round exclude?
The agency excluded 68 drugs that met volume conditions, for reasons such as low 2024 procurement value, weak competition patterns and high clinical usage risk. [18] Enzalutamide was excluded because of IP disputes. [19]
Why can China not yet launch a generic Ozempic?
Ozempic holds regulatory data protection in China until April 2027 under the China-Switzerland Free Trade Agreement. Novo’s Swiss entity holds the Chinese market authorization. [9]
How long does BIOSECURE grandfathering last?
Contracts signed with a biotechnology company of concern before its effective date are grandfathered for five years. The period starts when the Federal Acquisition Regulation is amended. [23]
Which companies pay zero Section 232 duty?
Firms with a most-favored-nation pricing agreement with the Department of Health and Human Services and an onshoring agreement with the Department of Commerce pay zero through January 20, 2029. [17]
How many products did the bulk drug PLI scheme plan, and how many are committed?
The scheme envisaged 41 products and 82,270 metric tonnes per annum. Investors committed 91,077 metric tonnes per annum for 33 products. [16]
What does Biopharma SHAKTI fund?
It funds an ecosystem for biologics and biosimilars over five years, with an outlay of INR 10,000 crore. The plan covers clinical trial sites, regulator capacity and pharmaceutical education institutes. [25]
Does China have a Paragraph IV equivalent?
Yes. A Type IV certification states that a registered patent is invalid or not infringed. It triggers a 45-day window for the patent owner to sue and a nine-month stay on approval. [22]
References
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