Ever changing Indian Regulatory System – History and Future

Date:01-31-2022

There was a time when Indian registration system was complex and most companies lacked the clarity about registration guidelines; including what are different guidelines under which registrations for technical can be applied, both TI and TIM. Apart from few big Indian companies and MNCs already working in Indian agrochemical industry, these guidelines were a mystery for most, especially for foreign companies. As a result, most foreign companies (mainly Chinese) relied on Indian partners for selling their products in India, as Indian company would get import registrations and market the products accordingly.

This was a time, when lot of Chinese companies signed exclusive agreements with Indian companies, who assured them registrations. Chinese companies were happy that their Indian partner is doing all complicated registration work and Indian partner was happy, that once registration is complete, Chinese source will only be working with them (since, under TI registration in India, once a source is registered they can authorise any Indian company to get 9(4) TI registration, so exclusive agreements gave Indian companies a sense of security to go ahead and invest time and money in registrations). Adding to already growing import registrations portfolio, in 2016, CIB introduced two more categories for TI, viz. TI v/s FI (technical import registration for products whose formulation are registered under formulation import) and TI v/s FIM (technical import registration for products whose formulations are registered for indigenous manufacturing), along with existing TI v/s TIM (technical import registrations for technicals registered for manufacturing in India) guideline. The primary aim was to open more ways for new products and sources to enter and work in the Indian agrochemical industry, to make industry more competitive. But this lead to more aggressive approach of Indian companies towards getting more TIs rather than TIMs and push for exclusive agreements. In a way it promoted monopolistic practices which were beneficial for few and exploitative for most. Import of agrochemicals was held by a few Indian companies and there was more focus on getting import registrations rather than setting up manufacturing units in India; as both TI and TIM were complicated registrations to get, but once TI was approved business was quick and more profitable and this was only increasing dependency on imported material.

Indian government and CIB both wanted to promote technical manufacturing in India, and in order to do so in December 2016, in CIB RC meeting 371 it was decided, that to reduce import, TI guidelines would be made stringent and to improve local manufacturing, TIM guidelines will be relaxed in favour of local manufacturers. As a result, Indian companies with both TI and TIM for same product, were asked to surrender their TI registrations; TI guidelines like TI vs TIM were scrapped. Data requirements for TI were increased and a validity period for TI registrations was also made mandatory. On the other hand guidelines for TIM registrations were relaxed, with lesser data requirements (5 Pack Acute toxicology was the major data dropped by CIB from TIM guidelines, limiting toxicology data to only AMES along with ATR) and TIM applications were being processed on priority. This encouraged more Indian companies to make TIM applications and set up technical manufacturing plants. This followed by CIB RC meeting 381 in December 2018, in which TIM v/s TI (technical manufacturing for technical registered for import), TIM v/s FI/FIM (technical manufacture against already registered formulation for import and manufacturing)  guidelines were introduced. These further eased TIM guidelines and encouraged more applications. In last 3 years with all these developments, foreign companies got an impression that getting TI registration in India has become impossible and cost have gone up too much, with long time required for data generation and approval of TI registration and TIM registrations have been liberalised to threaten TI registrations.

On the contrary this overhaul of guidelines for TI was the first step towards harmonisation of registration guidelines. What CIB, actually wants to achieve is a balance between both TI and TIM registration guidelines, in order to encourage international companies to bring in new chemicals and technology to India, and on other hand encourage Indian companies in taking up manufacturing here. The regulatory environment shouldn’t be penalising one or rewarding the other, and in order to do so in the current phase of reforms, CIB has introduced more data requirement for TIM registrations to get good quality products in market. As per the latest proposal by CIB following data will be required for TIM registration:

• ATR (existing requirement)

• AMES (existing requirement)

• 5 Pack Acute Toxicology (proposed additional requirement)

• 2.5 years shelf life data (proposed additional requirement)
  

If these data requirements are accepted and implemented by CIB, then for getting TIM as well the time period required would go up to 3.5 to 4 years from current 1 to 1.5 years. Similarly cost of registration would also increase. All these measures will create a level playing field for both TI and TIM registration holders. Moreover the overall registration application evaluation process is being streamlined by CIB, which would reduce the time taken for completion of registration. CIB has introduced an external agency viz. IITR (Indian Institute of Toxicological Research) to evaluate toxicology data used in TI and TIM applications. Although there will be an additional cost for this external evaluation, but the complete data will be evaluated in set time period of 6 months, which currently takes anywhere from 15 – 18 months. It is expected that CIB would be coming up with more such provisions for the applicants to save time and get registrations approved in timely manner.

The registration reforms will lead to a market scenario where both TI and TIM would complement each other instead of being a threat. International companies, which were recently reluctant in investing time and money in Indian registrations (due to regulatory benefits available with TIM applicants), can take a fresh look at the overall market scenario and re-strategise about their long term goals regarding the Indian agrochemical industry, as these reforms will continue to make Indian agrochemical industry more lucrative for both TI and TIM registration holders.