China remains the biggest source of bulk drugs and intermediates imports.

Monday April 11, 2022 at 12:11 pm

Imports of bulk drugs and drug intermediates from China for the first nine months of the previous fiscal year 2021-22 were reported. 17,610 crore, which accounted for nearly 66.48 percent of the imports. In the last fiscal year 2020-21, when the pharma sector in the country had reported a close to 10 percent growth, the imports of bulk drugs from China had also shown a noticeable increase in terms of actual numbers. However, the percentage of overall imports remained the same, according to data recently released by the union ministry of chemicals and fertilizers.

According to this data released by the union ministry at the beginning of April, India has imported 3.02 lakh MT of the bulk drugs and drug intermediates worth Rs. 26,490 crore in the nine months starting from April to December 2021. Out of this, the lion’s share of Rs. 17,610 crore worth of imports were from China alone.

During 2020-21, the total imports were 3.90 lakh MT of bulk drugs and drug intermediates, worth around Rs. 28,529 crore. Out of these, the Chinese imports were Rs. 19,403 crore, accounting for 68.01 percent. The reader must observe that in 2019-20, the imports stood at 3.64 lakh MT, worth Rs. 24,172 crore, of that, Rs. 16,443 crore (68.02 percent) was from China.

Meanwhile, the exports of bulk drugs and drug intermediates from India from April to December 2021 stood at 3.35 lakh MT, worth Rs. 24,107 crore. That was 3.24 lakh MT worth Rs. 32,857 crore in 2020-21, and 2.71 lakh MT worth Rs. 27,533 crore in 2019-20, said the ministry.

Bhagwant Khutba, minister of state in the ministry of chemicals and fertilizers, has recently claimed in the Parliament that the Indian Pharmaceutical industry is 3rd most extensive in the world by volume. India exported pharmaceuticals worth Rs. 1,80,551 crore in the financial year 2020-21. India has also exported bulk drugs and drug intermediates worth Rs. 32,857 crore in the last fiscal year 2020-21. However, the country also imported various bulk drugs and active pharmaceutical ingredients (APIs) to produce more medicines from several countries, including China.

“Most of the bulk drug/APIs imports are economic considerations, and China is also one of the world’s largest producers of KSM and API. The Committee, constituted by the Department of Pharmaceuticals, observed that there are 58 APIs, for which the dependency of the country on imports from China for these APIs varies from 50% to 100%,” noted the Bhagwanth Khutba, minister of state in the ministry of chemicals and fertilizers in Lok Sabha. The government of India has announced the production linked incentive (PLI) scheme in the pharma sector to address this high dependence on China for bulk drugs and intermediates.

According to the Annual Report of the Department of Pharmaceuticals for the fiscal year 2021-22, 500 API manufacturers are contributing to nearly 8% of the global API industry. Almost 90 percent of the World Health Organisation’s (WHO) pre-qualified APIs are already sourced from India.

In terms of the pharmaceutical strengths of the country, it was observed
that India already provides generic medicines to more than 200 countries, and eight out of 20 global generic companies are currently from India. With 741 sites being approved by the United States Food and Drug Administration (USFDA) as of August 2021 and 4,346 abbreviated new drug application (ANDA) market authorizations secured by Indian companies as of December 2020, over 55 percent of India’s total pharma exports is to highly regulated markets. Almost 65-70% of the World Health Organisation’s (WHO) vaccine requirements are sourced from the country.