The pharmaceutical manufacturer Akums Drugs and Pharmaceuticals Limited has announced India’s first homegrown indigenous Hydroxyurea oral suspension for the treatment of sickle disease in children at 1 per cent cost of the global price.

 Union Minister Mansukh Mandaviya also congratulated Akums for developing a medicine to prevent sickle cell disease.

  “Many congratulations to you for developing a medicine to prevent sickle cell disease. PM Modi launched the Sickle Cell Anemia Eradication Mission in 2023. This medicine will prove to be a boon, especially for our tribal sisters, brothers and children and we will soon free India from sickle cell,” Mandaviya posted on X by tagging Akums.

 Hydroxyurea Oral Suspension will be used for symptomatic management of sickle cell syndrome for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in adults, adolescents and children older than 2 years.

 On the development of the sickle cell anaemia drug under Make in India, Akums MD Sanjeev Jain told   that the price of the medicine developed in India for sickle cell anaemia is 1 per cent of the global price.

 “80 per cent population of this disease (sickle cell anaemia) is in Africa and India. We did some study and realised that we cannot eradicate this disease if its medicine is not available at a lower price. After some research, we have developed a medicine. The price is around 1 per cent (of the global price),” he said.

 “Secondly, it is stable at room temperature. Earlier, the patients had to come to the hospital to take the medicine, but this medicine can be administered where they are. This medicine can be stored at a temperature of 25C. It is suitable for children and adults. We worked on it for 2 years and we are ready to commercialise it. We are ready for the manufacturing also. We are hopeful that we will be able to provide this medicine for Rs 700-800,” Jain added.

 Talking about the production of the medicine, Sanjeev said that the company has the capacity to produce 2 crores bottles per month.

 “We are completely ready for the production (sickle cell anaemia drug). We have sent a commercial batch to the Drug Controller General of India (DCGI) for approval. We can produce 2 crore bottles per month,” he said.

The dosage of Hydroxyurea Oral Suspension is based on the patient’s body weight. The usual starting dose is 15mg/kg/day and the usual maintenance dose is between 20-25 mg/kg/day. The maximum dose is 35 mg/kg/day.

“Globally Hydroxyurea is available as a capsule and solution. Capsules can not be dose-calibrated and the solution needs to be stored at 2 to 8 degrees Celsius. Thus, there was a requirement for a formulation of Hydroxyurea that could be given based on body weight and is also stable at room temperature. This challenge was given to us by MoHFW and Dr V K Paul,” officials from Akums told .

“Our R&D team accepted the challenge and worked on multiple trials in two years. Finally, they succeeded and formulated a room-temperature stable oral suspension of Hydroxyurea. CDSCO (DCGI) asked us to do bioequivalence studies with a global brand. We completed BE studies and got approval from DCGI,” he explained further.

 The officials added that the Indian Council of Medical Research (ICMR) will guide Akums to conduct the Post Marketing Surveillance (PMS) study.

 “Once the product is commercialized within a month, as per CDSCO requirement, Akums needs to do a Post Marketing Surveillance (PMS) study. Akums is honoured that we will be guided by ICMR to conduct PMS under their guidance,” the officials said.

 The National Sickle Cell Anaemia Elimination Mission was launched by the Prime Minister on July 1, 2023, at Shahdol, Madhya Pradesh.