CSIR-IICT initiatives to reduce dependency for APIs and drug intermediates
Active pharmaceutical ingredients (APIs) and intermediates are the key components of any drug that produces the intended effects. India is largely depended especially on China for supply of APIs and drug intermediates. Now Indian Institute of Chemical Technology (IICT), Hyderabad, is collaborating with another Hyderabad-based integrated pharmaceutical company, LAXAI Life Sciences, to develop and manufacture APIs and drug intermediates. The initiative may help in reducing the dependency of the Indian pharmaceutical sector on Chinese imports of these ingredients.
IICT, a laboratory under the Council of Scientific and Industrial Research (CSIR), is working with LAXAI for synthesis of drugs being used in the fight against the Corona Virus. The collaboration will primarily focus on Umifenovir, Remdesivir and a key intermediate of Hydroxy Chloroquine (HCQ).
India, one of the largest producers of anti-malarial drug HCQ, has seen a spurt in demand in the recent weeks. India has sent HCQ to over 50 countries over the last few days, including the United States. The collaboration will result in a cost-effective process with minimal dependency on China for key raw materials. In addition, Remdesivir, which has been previously administered to Ebola virus patients, is currently under clinical trials to evaluate efficacy and safety against COVID -19.
Realizing that drug security and undisrupted access to essential medicines are critical for public health, the Union Cabinet chaired by the Prime Minister, has approved a special package for promotion of bulk drug manufacturing in India and reduction of our dependence on China.
LAXAI Life Sciences Pvt. Ltd. was established in the year 2007, with a vision to accelerate the discovery chemistry campaign of global pharmaceutical companies. Today LAXAI has grown into an integrated pharmaceutical company with presence in API / formulation development as well as API manufacturing.
The collaboration will use the know-how for commercial manufacturing of the products. LAXAI Life Sciences shall be one of the first few to commercialize these products. The manufacturing of these APIs and intermediates will be taken up at U.S. Food and Drug Administration (USFDA)/Good manufacturing practice (GMP) approved plants held by LAXAI through its subsidiary, Therapiva Private Limited.