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CDSCO’s digital move: The way forward?

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The Central Drugs Standard Control Organisation (CDSCO) is planning to develop a common software platform for all the states in India for online filing and processing of applications for the grant of drug manufacturing licences. The objective is to build a transparent system as well as keep up with global benchmarks. However, the industry experts believe that the move will come with its own sets of challenges as they discuss its pros and cons and offer helpful suggestions. By USHA SHARMA

Manufacturers should get adequately trained to prepare for the new process

The proposal of creating a common software platform for drug licenses management for all the states in the country is a welcome step. it harmonise the licenses issued all over the country. But, it will require support and co-ordination from all state drug control departments as well as manufacturers.

SV Veerramani, CMD, Fourrts Laboratories

Issue of drug licenses by state drug controllers in time is very important for the survival and growth of the pharmaceutical industry. If there are any delays or glitches in getting online, it can cause hardship to the manufacturers. Further, the staff in the state drug control department needs to be trained in the implementation of the systems and the systems also may require adequate upgradation and speed.

All along, the Indian Drug Manufacturers have been following a conventional path in getting their drug licenses and they have been going on smoothly. Now, the manufacturers also need to get adequately trained to make online application for drug licenses. Many manufacturers are apprehensive that there may be delays in implementation of the new system. Hence, more time needs to be given to them to comply with the new requirements. Initially, it can be made optional and later mandatory, once we arrive at smooth functioning of the system.

The sugam portal launched by the Central Drugs Standard Control Organisation (CDSCO) is running smoothly now except for some glitches in getting receipts for online payments made. While the system is accepting payment, it requires reminders to issue receipts for the payments, which is important for our records. I am sure, this will be sorted out soon.

Success of this portal will depend upon the back-end data

A robust single portal for the online approval in India, to obtain any kind of drug license approval is a great initiative by the CDSCO and Ministry of Health & Welfare. Primarily, implementation and success of this portal will depend upon the back-end data which has been used. We need to have all approved drugs, APIs, their combinations, excipients and dosage to be synchronised in such a way that for any available drug combination in the market if asked for a license should immediately be approved or rejected, based on the parameters and compliance of manufacturing. Apart from that, all the manufacturing units should have the complete online monitoring of manufacturing processes at their plant level, which can be checked by authorities any time, including their quality parameter which cannot be altered by human intervention. The objective of this is, when these processes will be in place, the system itself will approve/reject the three validation batches. That means, who so ever the manufacturer may be the ‘quality’ will be ensured before the standard approval by CDSCO.

Deepak Kumar Verma, GM, Zuventus Healthcare

Most importantly, to ensure that the manufacturers adhere to the system, a penalty standard should also be set-in. I believe, that the renewal of licenses should be done only if the drug manufactured by the unit for that approved period of license, adheres to 100 per cent compliance and if there is online rejection/recall of three batch any time in this period, that product should not get an approval for that manufacturing unit. This will help in keeping up the quality, ethical and healthy competition, reduce the load on the department and spurious drug manufacturing will automatically brought here to closure.

We should not adopt online system for the approval of “New Drug/Formulation” Now, but we need to continuously work on developing the model and take a call when the system for existing product/combinations becomes robust. The reason behind it is that for a new drug/formulation approval, there is a lot of new data which is generated by the researcher/manufacture. Their data will not be with department in prior, hence requires lots of studies/analyses/discussion before approval. this data can be uploaded so that after approval, it becomes a standard and a reference point for other manufacturers seeking approval. The role of drug inspectors and authorities then becomes very different, then they will be able to utilise their time in developing better processes and give their advice to the manufacturing plant to adhere to better compliance.

Secondly, training and development through the online portal should be the second very important aspect which needs to be considered. There should be a level wise examination to work in a manufacturing/R&D/ any institution where ever the scope of CDSCO goes. Online examinations needs to be conducted to qualify, to work in these units. Every level worker in the manufacturing unit must appear for the examination to qualify to work in the manufacturing unit. It is not the basics Qualification which should be the only criteria. The questions should be objective. But their sequences should be such that people cannot memorise the questions and cannot communicate to the other examines. This is possible when each question is given the time only read and answer, not to think. This will also help the manufactures management in deciding about the career plan and justification of salary to their employees.

I am of the firm opinion that to meet up to the expectation of international standards and survive in future, which is going to be a quality based market, price is not going to be a big factor. Where ever here is price concern to poor, the government should provide free medicines. The govt should focus on quality and not on price. Yes, there should essential drugs which should be in DPCO. I believe, medicines/drugs/formulations should have ONE standard in the world as, the disease is only ONE, across the WORLD. Therefore, there should be one standard, one process, and
one system for the manufacturing/analysis/approval of drugs in the world. Looking into the world’s current approach towards pharma manufacturing, each country is being challenged at all fronts.

Therefore to be in the completion and escalate the pharma business, it is the need of the hour that we up-scale our standards, meeting up to global standards and bring in policies to encourage API manufacturing before 2024.
I am confident that Indian Pharmaceutical Drug Authorities would be certainly working upon standardising the quality standards, matching the Global Standards. We are very hopeful that there will be a positive, digital transformation in the CDSCO online system, which will help improve the system, by adopting robust processes to strengthen the standardisation of the approvals to make India a quality driven country on the map of world of pharmaceutical manufacturing.

A robust e-governance system is the foundation for an effective compliant regulatory framework

As the demand for Indian made pharmaceutical products increases globally, we have a very sure possibility of investment in green field manufacturing and supply facilities. Timely approval and completion will be the key as the market is highly competitive and several other growing economies are competing with India to grab a significant share of global pharma market. We cannot afford to lose any of the opportunities. Moreover, new greenfield capacities mean more direct and indirect employment opportunities.

Himanshu Saxena, Founder Director, Sisha Pharma

It is a herculean task for the CDSCO and other ancillary agencies to manually monitor the cGMP status, licencing and various aspects of regulatory compliance for pharma manufacturing and supply. The step taken by CDSCO to bring an e-initiative to streamline the manufacturing licencing centrally through a central data base is a welcome step and need of the hour. India is aggressively pushing for increasing our share in the global pharma market and it is extremely important that we have a e-system of monitoring and governance.

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