Magazine 635

E-initiatives by Gujarat FDCA Revolutionising the Drug Sector in India

Dr Hemant Koshia
Commissioner, FDCA, Gujarat

The Food and Drugs Control Administration (FDCA), Gujarat, has adopted innovative and progressive policies for promotion of e-Governance in the State. Recognising the efforts made by the department in this space, the Government of India has awarded it with the National e-Governance Gold Award, says Dr Hemant Koshia, Commissioner, FDCA, Gujarat, in conversation with Gopi Krishna Arora and Hemangini S Rajput of Elets News Network (ENN).

Q. What is the Gujarat FDCA doing to ensure availability of safe medicines in the market?

In order to ensure the availability of safe drugs to the citizens, we have world-class technologies available in our laboratories and a well-trained team of Food and Drugs Control Administration to look into all safety issues. At Gandhinagar headquarters, we have structured organogram with joint commissioners-drugs manufacturing, joint commissioner drugs, joint commissioner-medical devices and joint commissioner-food to look after food safety. We also have deputy commissioners for blood safety, food, price control, manufacturing and drugs safety in Gandhinagar.

We have presence in all the districts of the State through assistant commissioners, who are assisted by senior drugs inspectors for manufacturing site and drug inspectors for the cell units located in the districts.

Besides, FDCA has presence up to the district level and a good network of intelligence units at all levels to take instant action against wrongdoers.

Apart from this, we have state-ofthe- art drugs laboratories, which are the first to have obtained National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation in the country. Having this accreditation helped us establish our credibility in domestic as well as international market.

Also, being the ‘pharma capital of the country’ we have more than 4,000 licensed manufactures and over 37,000 retail pharmacies. With the better use of e-Governance initiatives and advanced technology, we are managing the show efficiently.

Q. What steps are being taken by the FDCA to make regulatory set-up more transparent?

Food and Drugs Control Administration (FDCA), Gujarat, has adopted innovative and progressive policies for promotion of e-Governance in the State.

We have two major responsibilities – services and enforcement. As an enforcement agency our mission is to assure that the products are safe and truthfully labelled.

On the service front, we have always shown pro-active interest in adopting and updating our e-Governance initiatives from time to time. Our path breaking e-Governance initiatives ensure transparency in our work.

Q. What e-Governance initiatives have been taken up by the FDCA to inter-connect licensing, registration offices, laboratories and online applications for licensing?

We have launched many e-Governance initiatives like Xtended Licensing, Laboratory and Legal Node (XLN), XLN covers varied functions related to issuance of licenses, enforcement, laboratory management, availability of medicines, and monitoring of availability of blood and its components with the blood banks. The aim behind creating this system was to bring about transparency, traceability, simplicity, effectiveness, speed, accuracy and accountability in various G2G (government to government), G2C (government to consumers) and G2B (government to business) functions of the department.

Going extra miles, we have also been training all our officials on priority basis, by conducting continuous training programmes and induction training of newly-appointed officers. This has helped us to not only sharpen our knowledge base, but also maintain and further improve the performance of FDCA to achieve new landmarks.

All these initiatives make the department activities more transparent for the industry and the public. We have already computerised our day-today operations as part of our e-Governance efforts long back, as it is the right of the industry to know the status of their application.

Recognising the efforts made by Gujarat FDCA in adopting and implementing e-Governance initiatives that have been replicated in other States, the Government of India has awarded the department with the National e-Governance Gold Award.

Q. Gujarat being a “Pharma Capital”, what sets the State FDCA apart from other drug control departments in the country?

Gujarat has always been one of the frontline States in the implementation of e-Governance policies and projects in India to make system transparent. Many independent agencies have rated Gujarat as one of the most e-prepared States in the country.

Besides, the Gujarat is a well governed state and works with the vision of “Maximum Governance and Minimum Government” that sets us apart from other States in the country.

Recognising the efforts made by Gujarat FDCA in adopting and implementing e-Governance initiatives that have been replicated in other States, the Government of India has awarded the department with the National e-Governance Gold Award.

Q. What are the key issues and challenges that FDCA faces when it comes to regulatory compliance?

One-third pharma production in the country takes place in Gujarat and the State contributes 28 per cent of the total pharma export of India. The State’s pharma industry produces best quality affordable medicines. But still, there are some black sheeps in the market. Therefore, all this accomplishments bring along their own set of challenges. While in general the industry is fairly very co-operative and good in compliance, there have been some incidences of non-compliance among SMEs or MSMEs.

It has come to our notice that some small-scale manufacturers take law for granted by overlooking certain regulatory compliances, which are essential to ensure a long shelf life and quality of products. Lack of an efficient internal control or compliance system, inadequate utilisation of technology to identify red flags, etc are some of the issues that need to be addressed. We take strict action against those who flout the law.

As a regulator, Gujarat FDCA ensures proper compliance and implementation of the food and drug regulatory practices like licensing of manufacturing units, giving approval for test and analysis, conducting post marketing surveillance and routine inspections and prompt investigation after receiving complaints.

Apart from ensuring proper implementation and monitoring, we also make sure that law violaters are not spared. As punitive actions, we make sure that the licenses of the guilty are either suspended or cancelled along with filing and building appropriate case against them as the situation demands. We do this with the help of our strong work force of highly skilled and trained food and drug officials.

As a regulator, it is our duty to ensure that industry follows all the good regulatory practices and comply with the law of the land and work towards ensuring that the quality of the products are not compromised with.

Q. Do you think strengthening of existing and creation of new drug testing laboratories is essential to ensure the quality of drugs being produced in India?

Currently, Gujarat has the largest and oldest drug testing lab in the country with the latest medical equipments, trained manpower and technology. Because drug is a science and technology-based industry, laboratories act as a backbone for us. We take samples and test them regularly with the help of worldclass technology available in our laboratories and nab wrongdoers to ensure safe and secure drugs for all. We are also planning to come up with a new state-of-the-art testing lab at Vadodara for which the central government has approved Rs 55 crores.

Our Goal

  • To reduce Maternal Mortality Rate of Gujarat
  • To reduce Infant Mortality Rate of Gujarat
  • To reduce Neonatal Mortality Rate of Gujarat
  • To increase Sex Ratio of Gujarat
  • To reduce anaemia burden in population
  • To reduce disease burden of Communicable Diseases and Non- Communicable Diseases
  • To reduce, control and manage water-borne diseases and vector-borne diseases

Q. What are the new projects that the Gujarat FDCA is currently undertaking to keep up with the change in monitoring and regulation?

We have state-of-the-art testing laboratories to ensure best possible monitoring. We are always ready to adopt the best and world-class technologies available globally. Gujarat FDCA is equipped with hand-held devices and mobile testing labs. The hand-held devices are high-tech in nature with which we can detect the components available in a drug within seconds without breaking the container of injections, capsules and tablets during raids.

Q. How do you rate the industrial policies in Gujarat, especially for the pharma sector? Where does Gujarat stand when it comes to initiating industry-friendly policies?

We have a very good law and order situation, and the state is also power surplus which is a prerequisite for any industry to grow. Trained manpower is also essential for any industry to thrive, and we have many pharmacy institutes located in Gujarat. There are research and development centres engaged in inventing new drugs. Altogether, these conditions provide a very good business environment, especially to the pharma sector. FDCA has always adopted friendly and transparent policies, helping newcomers in the industry to grow organically.

Q. Gujarat has slipped to the number three position in the recent ease of doing business ranking in India, what is your take on this?

Gujarat remained on top for many years in ease of doing business. We are redesigning our business policies and process reengineering has already been initiated. I am confident that very soon we will regain the number one rank in ease of doing business in India.

Q. Pharmaceutical marketing and aggressive promotion also contributes to irrational use, do we have any code for identifying and penalising unethical promotion on the part of pharma companies?

To combat the unethical and spurious drugs, we have very strict laws and fast trails to deal with such cases as this is a heinous crime and we don’t allow someone to play with the life of citizens. In such cases, we immediately lodge FIRs with the police and send criminals behind the bars.

Q. What are the present policies that promote production and consumption of healthy food in the State?

Gujarat is a well-known destination as far as food industry is concerned. The State is the largest producer of cumin, potato, banana, oils and food grain. We have many food parks cold storages in place. Recently, the Government of India has also announced three mega food parks in the State.

Q. Food Safety and Standards Authority of India (FSSAI) has rolled out a scheme for strengthening the food testing system in the country with an outlay of Rs 481.95 crore, what is your opinion about that?

At present, we have three testing labs in the State. Of these, two are food testing labs (at Rajkot and Bhuj) and one is a food and drug testing lab at Vadodara. Under the same scheme, we have also applied and got sanctioned Rs 50 lakhs in first phase to upgrade our Rajkot and Bhuj laboratories as per the requirements set by the Food Safety and Standards Authority of India.

Gujarat has strong fundamentals — its entrepreneurial people, excellent infrastructure, stable governance and business friendly policies make the state best destination for doing business.

Q. Any suggestions that you would like to give to the food and pharma companies which are looking to be in Gujarat as part of their expansion plans?

Gujarat has strong fundamentals — its entrepreneurial people, excellent infrastructure, stable governance and business friendly policies make the State best destination for doing business. We are always welcoming the new entrepreneurs to grow with us, as Gujarat is already a top producing State in food, its pharma and the quality of the goods are better as compare to those being produced in other part of the country.

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