Decentralize operations of CDSCO: TS govt urges Centre

Currently India is having a very complex regulatory system to approve the new drugs and vaccines compared to other countries in the world

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CDSCO FDA

In order to fast-track the development of new drugs and vaccines for containing the widely spreading coronavirus in the country, the state government of Telangana has written a letter to the Union health ministry urging it to decentralize the operations of Central Drug Standards Control Organization (CDSCO), so that some of the clearances and approvals which do not require high level scrutiny at the CDSCO headquarters can help in fast-tracking clearances for clinical trials, new drugs and vaccines in the country.

In his letter to the Union health minister, K. Taraka Rama Rao (KTR), minister for industries, government of Telangana, has noted that the state government of Telangana is very much keen to bring out an effective vaccine to annul the fast spreading deadly coronavirus. As part of this, the government has been doing all it can to support and encourage the vaccine manufacturing companies in the state. However the minister also urged the Union health ministry to initiate further steps for the speedy clearances of clinical trials and new drug approvals through fast track procedures through decentralization of operations of CDSCO at the state level offices.

“At this juncture of healthcare emergency, it is high time we need to streamline our approval and clearance process for new drugs and vaccines through fast track procedures. Not just approvals, the central government must also take early steps to speed up licensing process so that the drug companies can expedite the manufacturing process. In addition to this, it is also important for the Central government to come out with proper procurement policy and funding support for vaccine development in the country,” observed KTR.

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At present all the pharma companies which are involved in the manufacture of vaccines and drugs need to send their samples to the Central Drug Laboratory (CDL) at Kasuli in Himachal Pradesh. However, due to COVID-19 pandemic and other logistic problems many companies are unable to send the sample batches to the CDL. These problems were also brought to the notice of Drug Controller General of India earlier. However, the DCGI had already taken note of this issue and had asked the vaccine manufacturing companies to forward only the summary of each batch and lot to the CDL through email along with necessary undertakings. Though some of these issues are resolved on a temporary basis, the Industries minister wants the central government to take more efforts so that the pharma companies can be given more accessibility and flexibility by the drug regulation body.

For Indian companies to be more competitive and efficient, the industries minister pointed out that it is critical to decentralize some of the clearances and approvals which do not require very high level scrutiny at the CDSCO headquarters.  He also said that as the CDSCO is already having its zonal offices along with sophisticated drug testing laboratory, only thing that is required is to instruct the CDSCO to delegate more powers and authority to the zonal offices.

Currently India is having a very complex regulatory system to approve the new drugs and vaccines compared to other countries in the world. It is learnt that there are six different ministries at the central and state government level that give approvals for vaccines. In view of this, for Indian companies to compete with the global players, experts suggested that India needs to have a regulatory framework that can hold good for the global competition and ensure quality with accelerated speed.

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