The Drug Technical
Advisory Board (DTAB)'s move to approve change of name of the ‘Central Drugs
Standards Control Organisation (CDSCO)’ to ‘Indian Drug Administration (IDA)’
will now mandate a dedicated pool of qualified workforce to man regulatory
system. This will take India on a global platform like that of US FDA and EMA,
said Dr BR Jagashetty, former National Adviser (Drugs Control) to MoHFW &
CDSCO.
Following the 75th meeting of DTAB held on January 3, 2017, the Board’s approval to rename ‘CDSCO’ as ‘IDA’ to make it simple and befitting to its activities is the best that could happen to India’s regulatory office, he added.
During 2014, it was Dr Jagashetty in his role as the National Advisor who pressed for the CDSCO to be transformed with a name change to IDA and be given a different identity for an immediate recognition as an Indian Regulatory Authority across the globe. “Now the IDA will lay the foundation for qualified pharmacy professionals and this will automatically spur rapid license approvals in a transparent and efficient manner,” he said.
Once the name change is approved then the Government of India may direct all states to incorporate similar names in their states for administration of drugs like respective State DA (Drug Administration) or Respective State FDA (Food & Drug Administration) to bring in uniformity throughout country.
At the same time the Government of India should also introduce the Indian Drug Services (IDS) examination through UPSC for candidates to lead the IDA. This examination needs to be designed on par with the Indian Administrative Service (IAS), Indian Police Service (IPS) and Indian Foreign Service (IFS).
This IDS cadre may be known as Drugs Control Officers instead of Inspectors. They could be selected through UPSC and posted to various State DA or State FDA like that of IAS/IPS/IFS cadre. As and when required their services could be obtained or on deputation to IDA or other departments of health & family welfare, Ayush, food, veterinary, forest, chemicals, fertilizers, agriculture, industry, revenue, patents etc depending on the need. The position would exercise focused drug administration including framing and implementation of policy in consultation with the related ministries. Further, such a system would create a proper hierarchy and bring in a systematic reporting structure which is uniform to both Centre and State, Dr Jagashetty had said in an earlier interaction with Pharmabiz.
Dr Jagashetty, who was also the erstwhile chairman of the DCC sub-committee for Amendments to Drugs & Cosmetic Rules constituted by DCGI, feels that the Indian drug regulatory authority which scrutinizes the worlds’ third largest manufacturing base of pharma products by volume and 14th in value terms needs to have a more powerful image internationally.
In an era where patent expiry opens up opportunities for IDA personnel to approve not only branded biologicals but biosimilar and generic formulations, apart from new drug delivery devices like skin patches and inhalers. This is an age of innovation where information technology reigns and therefore online issue of licenses for sales and manufacturing and instant information of pharma companies will need in-depth skill training.
“It is high time that CDSCO aligns itself to its change of name to IDA to be more appropriate in the current context of developments of Digital India, Make in India, Uniform Code Pharmaceutical Marketing Practices (UCPMP), medical devices policy, price monitoring cells,” said Dr. Jagashetty.
Following the 75th meeting of DTAB held on January 3, 2017, the Board’s approval to rename ‘CDSCO’ as ‘IDA’ to make it simple and befitting to its activities is the best that could happen to India’s regulatory office, he added.
During 2014, it was Dr Jagashetty in his role as the National Advisor who pressed for the CDSCO to be transformed with a name change to IDA and be given a different identity for an immediate recognition as an Indian Regulatory Authority across the globe. “Now the IDA will lay the foundation for qualified pharmacy professionals and this will automatically spur rapid license approvals in a transparent and efficient manner,” he said.
Once the name change is approved then the Government of India may direct all states to incorporate similar names in their states for administration of drugs like respective State DA (Drug Administration) or Respective State FDA (Food & Drug Administration) to bring in uniformity throughout country.
At the same time the Government of India should also introduce the Indian Drug Services (IDS) examination through UPSC for candidates to lead the IDA. This examination needs to be designed on par with the Indian Administrative Service (IAS), Indian Police Service (IPS) and Indian Foreign Service (IFS).
This IDS cadre may be known as Drugs Control Officers instead of Inspectors. They could be selected through UPSC and posted to various State DA or State FDA like that of IAS/IPS/IFS cadre. As and when required their services could be obtained or on deputation to IDA or other departments of health & family welfare, Ayush, food, veterinary, forest, chemicals, fertilizers, agriculture, industry, revenue, patents etc depending on the need. The position would exercise focused drug administration including framing and implementation of policy in consultation with the related ministries. Further, such a system would create a proper hierarchy and bring in a systematic reporting structure which is uniform to both Centre and State, Dr Jagashetty had said in an earlier interaction with Pharmabiz.
Dr Jagashetty, who was also the erstwhile chairman of the DCC sub-committee for Amendments to Drugs & Cosmetic Rules constituted by DCGI, feels that the Indian drug regulatory authority which scrutinizes the worlds’ third largest manufacturing base of pharma products by volume and 14th in value terms needs to have a more powerful image internationally.
In an era where patent expiry opens up opportunities for IDA personnel to approve not only branded biologicals but biosimilar and generic formulations, apart from new drug delivery devices like skin patches and inhalers. This is an age of innovation where information technology reigns and therefore online issue of licenses for sales and manufacturing and instant information of pharma companies will need in-depth skill training.
“It is high time that CDSCO aligns itself to its change of name to IDA to be more appropriate in the current context of developments of Digital India, Make in India, Uniform Code Pharmaceutical Marketing Practices (UCPMP), medical devices policy, price monitoring cells,” said Dr. Jagashetty.
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