Express Pharma

‘It is our job to ensure that the drugs manufactured in Telangana maintains high quality’

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Dr Akun Sabharwal, IPS, Director, Drug Control Administration, Telangana, Hyderabad has been working aggressively in streamlining the regulatory mechanism and maintaining transparency in the system, since he took charge of the Drug Control Administration, Telangana.In an interview with Usha Sharma, he unfolds his plans for the state DCA

You passed out as an IPS officer and now has been deputed as a director of the Drugs Control Administration of Telangana. Tell us about your experience so far. How demanding is your current profile than previous one?

20160115ep04I took charge as the Controller of Drugs for Telangana State in March 2015. Although a regulatory job, this has been different than my previous assignments which revolved around policing. The last nine months have been a great learning and working experience. I lead a team of highly qualified people who are specialists in their chosen field. Within a short period, we have made efforts to improve the regulatory mechanism in pharmaceutical manufacturing and sales. The Drug Control Administration (DCA) has conducted a series of raids in manufacturing facilities; corporate hospitals, online pharmacies, blood banks and pharmacies/ drug stores across the state in which several violators have been booked. We have started an awareness campaign ‘No Bill, No Pill’ to curb issuing of medicines without prescription. This is to check development of antibiotic resistance due to indiscriminate use of medication.

It has been almost one and half years, since the new state of Telangana came into existence and hence the DCA of the state happens to be the youngest in the country. What challenges did you face?

Telangana is the hub of API (Active Pharmaceutical Ingredient) and vaccine manufacturing in India. The DCA has made efforts to ensure that the highest standards of quality manufacture, distribution and lab practices are followed in the state. In the last one and half years, Telangana has made major strides to emerge as one of the best regulators in the country.

Use of technology

  • State-of-the-art hardware and a Wi-Fi campus.
  • Computerised licensing process
  • Digitisation of our laboratory using the eLabs software which ensures transparency and reduces human error
  • Mobile App ‘DCA Inspection’ has been developed and our sales inspection is paperless
  • Use of bulk SMS to inform changes

Training of manpower

  • In-house training from university and industry leaders
  • By US FDA and CIPS
  • CDSCO sponsored

Reducing red-tape

  • Introduced the concept of timelines. Thus, the licensing process is completed within the time limits mentioned on our website
  • Self certification procedures

Challenges we face

  • Expansion to be able to take care of the needs of the growing industry especially the Pharma City.
  • Manpower: Due to state bifurcation, 58 per cent of the manpower has gone to AP whereas the large part of the industry is in Telangana
  • Training: The inspectorate staff needs to be trained with the best in the world

The state has a total number of 468 manufacturing units which includes SMEs and MSEs units as well. What assurance would you like to give to ensure that the drugs manufactured from these facilities have maintained the quality requirements of the Indian as well as developed countries?

It is our job to ensure that the drugs manufactured in Telangana maintains high quality. We are the first regulatory set-up in India to shift from an area approach to verticals as followed in the US. Thus, our drug inspectors are organised into six specialities viz

  1. Drugs and APIs
  2. Cosmetics
  3. Veterinary and animal products
  4. Blood and biologics
  5. Vaccines
  6. Medical devices

This ensures better supervision and quality regulation.

The Centre has made a provision of Rs 1750 crores to improve the drug regulatory mechanism, out of which Rs 850 crore have been sanctioned for all the states. How much has the Drugs Control Administration of Telangana demanded from the Centre and where are you going to invest it?

We have signed an MoU with the Union Health Ministry for Rs 28 crores for upgradation and strengthening of the DCA in Telangana. Of this, 75 per cent i.e. Rs 21 crores will be borne by the Government of India (GoI) and the rest by the state government.

This amount, to be used over a period of three years, will be used to equip the DCA team with better regulatory abilities and improve our laboratory.

You have proposed for the fresh appointment of joint director, assistance director vigilance and deputy director NT (Admin). How will these posts add value to the structure?

A post of joint director exists in Telangana. We have proposed another so that the work load is effectively divided between the two. An assistant director (Vigilance) is important to ensure that the corrupt and unethical practices do not take a ground in this department.

The administrative work of the department is increasing. Once the ‘Pharma City’ is set up, this will rise further. Thus, a deputy director (Administration) will be needed so that the other officers can devote their time to professional work rather than these matters.

Earlier this year, the Department of Health, Ministry of Health and Family Welfare have decided to redefine ‘Not of Standard Quality’ drugs and proposed certain changes in Section 36AC. How many samples have your department received and out of the total, how many samples have been tested so far?

The officers of DCA, Telangana regularly pick up drugs for testing the quality. On an average, an inspector has to collect five samples per month. These are then sent to Drug Control Laboratory, Hyderabad for analysis. From January 1, 2015 till date, around 5200 different samples of drugs/ medicines have been analysed in Telangana. Out of these, 46 were found to be of ‘Not of Standard Quality.’

The CDSCO has recently launched SUGAM website for online licensing system for upcoming pharma units, Your say on this

This is a welcome move. The DCA, Telangana has already computerised most of its licensing work. Once the CDSCO also takes to this, the quality and time parameters will improve.

The CDSCO has allowed state authorities to issue the grant of no objection certificate (NOC) for conducting BA-BE studies in India. How positive and industry-friendly move is this?

This is a positive and industry-friendly move for a state like ours which has the human and material ability to regulate properly.

What are your expectations from the central government or the CDSCO?

  • Better co-ordination.
  • Training opportunities to state regulators.
  • Support for NABL accreditation of DCLs.

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