The whole bone of contention is the provision of specific clauses in the Bill, especially Section 12(6) and 12(12). Section 12(6) basically provides exclusivity to the test data submitted by the original registrant of a new pesticide sought to be introduced in the country. This data cannot be accessed or relied upon to grant registration to another company wanting to market the same molecule for a period of three years. The me-too registrant would have to furnish separate data to obtain market approval for the same pesticide, a provision that does not exist in the 1968 Act. On the other hand, Section 12(12) apparently leaves no scope for even submitting fresh test data. It simply states that new registration in respect of a pesticide, data of which cannot be relied upon, shall not be granted during a period of three years of the date of its registration, unless accompanied by a letter of consent from the original registrant. What this effectively does is to provide protection to even off-patent molecules or those for which patents were filed prior to January 1, 1995, the cut-off date for eligibility of product patents.
During the period of data exclusivity the multinationals will have a free run as alleged by many of the industry majors. The multinationals, on their part, contend that generating field trial data entails costs. The multinationals had, in fact, lobbied hard for a 5-10 year data protection, whereas the Bill has limited this to three years. The Bill also provides for relaxation in the exclusivity period in the event of national exigency, in cases of urgency and public interest.
The bill seeks to regulate the import, manufacture, export, sale, transport, distribution, quality and use of pesticides with a view to control pests, ensure availability of quality pesticides, minimise the contamination of agricultural produce, create awareness among users regarding safe and judicious use of pesticides, and take necessary measures to continue, restrict and prohibit the use of pesticides with a view to preventing its risk on human beings, animals and environment.
Compulsory registration is a good step towards curbing the sale of spurious pesticides and minimise residual contamination but the concerns has to be rightly addressed keeping intact the issues, interest, long term gains of stakeholders and environmental safety at large.
Some protectionism for the domestic manufacturers and industry has to be adopted by the government before the bill gets passed and enforced, which for the western nations are well known for and openly promote, in case of the home grown corporations. While all pesticides will have to be registered after the enactment of the law, the most deleterious cause, the party maintains, pertains to the one on data exclusivity, which, it claims, was brought in under the Western/ MNCs pressure. Under the data exclusivity provision, the researcher’s data will be his monopoly, and no one else in the world would be allowed to have control over it. Monopoly can also lead to exploitation, and a hike in the prices of pesticides. Such a clause will have dangerous consequences for a country like
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