‘The pharma industry of Gujarat is facing no challenges’

‘The pharma industry of Gujarat is facing no challenges’

Recently promoted as Commissioner, Licencing Authority, Food and Drugs Control Administration (FDCA), Gujarat, H G Koshia has long been involved with the state’s drug regulatory mechanism. Viveka Roychowdhury quizzes Koshia on the FDCA’s initiatives

What were challenges facing the pharmaceutical industry and Gujarat in particular, during your tenure in the FDCA?

Presently the pharma industry of Gujarat is facing no challenges. The era of difficulty due to competition from tax free zones in the north is gradually getting relieved. The present infrastructures facilities enjoyed by the Gujarat drug industry are better with respect to roads, power, water supply and transportation. Technically competent and skilled staff is also an added benefit to the manufacturers of Gujarat drug industry. With linkages with the export business, quality reputation and updated technology, pharma sector is thriving towards new horizon of growth and development.

Looking at the year ahead, what major regulatory changes is the government contemplating? What are your views on the moves of the government to centralise India’s drug licensing system?

The system for centralisation of drug licensing has its pros and cons as well. In the era of research, advance technology and globalisation, lot of new things from all around the world are coming up in the pharma industry which can be very well tackled by central licensing system. Moreover, the co-ordination, harmonisation and uniformity amongst the states and implementation and enforcement of Drugs & Cosmetics Act 1940 can also be monitored by the system of centralisation. Therefore, the system is a welcome move upto a limited extent. However, in order to safeguard the interest of small and medium enterprises (SME), it is necessary that the powers vested to the State Licensing Authority for conventional work be retained intact.

Irrational Fixed Dose Combinations (FDCs) have become a health hazard for the consumer. What are the steps taken by the Gujarat FDCA to curb this practice?

This is a sub judice matter. Some associations have already secured stay orders from the Chennai and Pondicherry High Courts. Under the circumstances, this department has to maintain the status quo for the implementation of High Court orders. Regarding the manufacturing, marketing and availability of 294 Fixed Dose Combinations (FDC), this department has already ensured that the manufacturing, marketing and availability of such drugs may not take place. The product licence of such combinations is also cancelled. All the manufacturing licensees of this additional product are already ordered to stop the manufacturing right from the date of the order of Drug Controller General (I). Thereafter this department is not issuing any such drug license.

Similarly, what are your views on the attempts to define ‘counterfeit drugs’ by international agencies like the WHO’s International Medical Products Anti-Counterfeiting Taskforce (IMPACT)?

The definition of counterfeit drug devised by international agencies like WHO, International Medical Products Anti-counterfeits’ Task Force is somehow required to be given a second thought to match with the ethnic situation of India. The definition of counterfeit should be strictly and specifically differentiated in terms of labeling and quality. The provisions for counterfeit drug which is fraudulently mislabeled with respect to its original manufacturer should not coincide with the provisions of spurious drugs containing zero ingredients of active medicaments. The drug which is going to be harmful and cause serious hazard to the health of human being should be categorised separately for stringent penalty. To us, the therapeutic effect and quality of the drugs should not be a synonym for graphics, design, logo and label of drugs. The definition of ‘counterfeit drugs’ and ‘spurious drug’ must be earmarked with this specific difference

What are the steps taken by the FDCA to put a stop to the activities of spurious drug manufacturers and those involved in the marketing of such products? Could you give some statistics on the cases solves/penalties implemented in the past few years in your tenure?

The Gujarat FDCA enjoys countrywide reputation for its prompt and effective enforcement officers’ team. Under such circumstances there are no chances for unscrupulous elements to make this state a ground for their nefarious activities. The officers’ team of Gujarat FDCA is always alert and vigil to strike and take initiatives in advance for any type of threat from such elements. The tenure of present Commissioner is of course a brief one. However, during the period of my services as a Joint Commissioner some landmark achievements have been noted to penalise those who are involved in these nefarious activities. For example – one person has been arrested under PASA (Prevention of Anti Social Activities) for indulging in business of spurious drug manufacturing. This example is good enough to give strong and red signal for wrong doers to remain away from Gujarat State.

The Drugs and Cosmetics Act was to be amended to put a high penalty on spurious drug manufacturers and those involved in their marketing. What is the progress on this front?

Presently a bill to amend Drug & Cosmetics Act is in the process of being passed through the formal proceedings at Central Government level to impose a high penalty on spurious drugs manufacturers. We strongly believe that those who are playing games with life and health of human being should not be spared and stringent punishment is definitely a welcome step in the proposed amendments.

What has been the growth rate of the Gujarat pharma industry in the last five years? What have been the key growth drivers?

The segment of the pharma industry in Gujarat state has witnessed consistent and sustained growth and development barring only few instances. During the era of competition from tax free zones in the northern belt, the industry has to wait and struggle for breath. However, within a very short time it has recovered with the same speed and pace and is now able to maintain double digit growth. The tentative annual growth at the world level in Gujarat pharma Industry is above two digits. Well developed industrial infrastructure, key research work and technically sound base of manpower could bring back developments. Large domestic market and growing export business are the key factors playing major role in the development of Gujarat pharma industry. Some other factors which are also being counted as growth drivers in Gujarat pharma industries are skilled manpower, pro-active and professional management by the State Government and availability of cost advantage raw materials.

How has your department coped with the increase in manufacturing establishments in the state? What is the current strength of your field staff? What are your initiatives on the staff training?

It is a matter of fact that the departmental staff is not getting increased vis-à-vis number of units increasing in manufacturing field. However, the staff of the department is well trained and professionally skilled to discharge the duties assigned to them. Strategic arrangement, technical expertise and administrative skills are also an important part to handle the situation successfully. At present the department is facing shortage of staff. Nevertheless the efforts are going on to fill up vacant posts by promotion and direct selections. At present this work is on the priority agenda points of the department. Regarding training work, all the technical officers of this department have recently undergone a “Regulatory Officers Training” course for 15 days held at the National Institute of Pharmaceutical Education and Research (NIPER), Chandigarh. The officers are always encouraged to participate in workshops, debate training on regular basis being held by Indian Drug Manufacturers Association (IDMA), Indian Pharmaceutical Association (IPA), academic institutes, etc.

How does FDCA work on the consumer awareness front?

For increasing consumer awareness the senior officers of the department are arranging public meetings for drug quality. The senior officers of this department also take lectures and give speeches in workshop being held by Druggists & Chemists Associations. In case of blood banks, the programme conducted by charitable institutes/ Red Cross Society, etc. are also actively assisted by officers of this department. The Food and Drugs Laboratory of this department is well equipped with exhibition and demonstration materials for creating awareness in social groups, NGOs, academic institutes, etc.

What has been the FDCA’s investment in IT applications to increase efficiency and streamline procedures?

All the circle offices of this department are provided more than one computer at each place and they are linked with the head office. The software module for drug sale licence is already operational in this department. The data and information regarding drug sale licence is freely accessible to the public. The computerisation of the issuance of drug manufacturing licence is at advanced stage and is ready to be launched at any moment, to issue first online certificates for Certificate of Pharmaceutical Product (COPP) to the applicant. The statistical information and data are already built into the software for this purpose.

InformEx will be making its debut in India at Ahmedabad this year. How has been the industry’s response to this event so far?

This is the first time in the history that InformEx USA is going to be organised in India, ie, in Ahmedabad, Gujarat State. The pharma industry of Gujarat is definitely going to reap advantages out of this. However, on account of global recession and Mumbai blasts, the participation of international delegations may be slightly affected, but as far as the involvement of domestic industries concerned, there is no doubt that the event will prove to be a total success. The industry has been sensitised to this programme and the response is quite encouraging one.

What is your role and responsibilities towards making this event a success?

The Government of Gujarat has officially authorised the Commissioner of FDCA to visit and participate at InformEx USA. The Commissioner paid a visit to the venue and thoroughly studied the programme. His extensive and exhaustive study of this event is going to be fully utilised in same manner in Gujarat State too. The Informex India which is going to be held in Gujarat state is a tripartite agreement between the Government of Gujarat, industry associations and UBM India. The Food and Drug Control Administration, Gujarat State is active and conscious to take all the necessary steps to see that the global programme offers the best to be delivered to all segments of the pharma and Specialty Chemical industries.

How will such an event benefit the industry?

InformEx INDIA 2009 is going to offer a B2B meet, CEO Conclave, Seminars, Workshops etc for prospective entrepreneurs. The potential buyers from international level will be able to interact directly with the local manufacturers enabling them to identify the customer and area for their market.

The capability of the Indian players to manufacture world class Active Pharmaceutical Ingredients (API) and pharma at competitive rates will definitely help to make them global players and enhance their business potential especially during this time of recession.

Do you see any slowdown in this sector in Gujarat due to the global economic crisis?

The global recessionary crisis and Mumbai blasts are expected to create some effect to slow down the programme. However international buyers and global investors may not be getting discouraged which is apparent on the basis of the fact that Memorandum of Understandings (MoUs) signed by investors comprise foreign companies too. Moreover, the growth in Gujarat pharma industry will also play a major role at this event.

Inspite of the global recession crisis, recently the VGGIS-2009 (Vibrant Gujarat Global Investors Summit) held on 12th – 13th January 2009 in Gujarat State witnessed an impressive enthusiasm from all around by entrepreneurs and 27 companies signed MoUs to offer investments of Rs 3249.31 crores in pharma sector alone. These proposals are already in the way of coming up. During the course of two days in VGGIS 2009, a total of 8662 MoUs worth $243 billion (over Rs 12000 billion) were signed which shows the potential for investment in the state of Gujarat. This way the event of InformEx INDIA 2009 will definitely prove to be a blessing for them. Therefore, overall picture for Informex INDIA 2009 seems to be bright.

After setting the stage for chemical and pharmaceutical professional looking to develop outsourcing relationships for pharma production in USA last month, InformEx is all set to establish its launch in India. InformExINDIA is organised by UBM India in partnership with the Government of Gujarat and pharma and chemical industries. It is designed to showcase the chemistry capabilities of high-value, high-quality business in the chemical manufacturing industry. The exhibition will host more than 40 exhibitors and major domestic pavilions from known industry association like Chemicals, Pharmaceuticals & Cosmetics Export Promotion Council (Chemexcil), Pharmaceutical Export Promotion Council (Pharmexcil), Indian Drug Manufacturers Association (IDMA).

Other concurrent events at the venue include a technical presentation and buyer-seller meet, (12-14 March 2009), where Pharmexcil will invite FDA/drug regulatory authorities, buyers, importers etc. from the Gulf Cooperation Council (GCC) and Middle East countries. A conference for the chemical industry is also being organised on 13 March 2009, by the Indian Chemical Council (ICC) to focus on different issues touching the current economic scenario as well as the steps to overcome it. The conference session will focus on key aspects of chemical industry like survival in slow down, history—Indian dyes and pigments, green manufacturing and environment and ecology. For chemical and pharma manufacturers and traders looking to capitalise on the increasing growth path of the chemical and pharma industry, InformExINDIA provides the perfect opportunity.