Main Objectives of the Confederation of Indian Pharmaceutical Industry (SSI) are :-
- To bring together the members of Industry Associations into a body and to form a forum for representation to the Government or the other Public Authorities, Mercantile and Public bodies in India and elsewhere.
- To educate all those who have interest and / or stake in the Pharmaceutical Industry in SS (Small Scale) in the various matters connected with the Industry, to position or direct the Manufacturers on a purposeful role in relation to the welfare of the Public and the Society.
- To further mutual assistance on Industry problems and to make representations to the Governments (State and Central) upon matters pertaining or related to the Industry.
- To watch and protect the general, commercial and business interest of the members and to take steps to advise them whenever it is necessary.
- Protection from amended law for spurious drugs punishment that treats us like terrorists having stiff penalties and non-bail able provisions:
As members are aware new provisions have been added in the amended Drugs and Cosmetics Act in respect of failure of drugs. This has created a lot of stress for all of us as the new provisions are very harsh and treat us like criminals. Under this new law an affected manufacturer may not get bail and will be get a jail term at par with criminals and terrorists.
- The punishment is so harsh that if any company committed the offence under section 27(a), he or she shall be punishable within imprisonment for a term which shall not be less than 10 years, which may be extended to life and shall also be liable to fine which shall not be less than 10 lac or 3 times value of the drugs.
- If any company committed an offence under 27(b), punishment shall not be less than 3 years which may extend to 5 years with fine which shall not be less than 1 lac rupees.
- If any company commit offence under section 27(c) shall be punishable which is not less than 7 years which may extend to life with fine which shall not be less than 3 lac.
- All the offences are non-bailable.
- Managing director, directors, manager secretary other officers, manufacturing and testing staff can be prosecuted and punished accordingly.
This is totally unjustified as the incidence of spurious drugs is a only 0.34% according to a recent nation wide parliamentary survey. Our association is striving hard to get some harsh severities of this law repealed to bring much needed relief to all of us. As a minimum bail must be allowed and for that we can contact our political well wishers politician and even approach the highest court of law.
- CIPI to continue defending its pending cases in different courts of law as decided in earlier meetings.
- CIPI in the recent past, has been successful in obtaining many stay orders against various harsh and unjust legislations of the government. We are confident and 100% geared up to successfully defend all these stay orders, even if we have to approach the highest court i.e. Supreme Court of India. All these stay orders are in our favour as our stand is just and honourable. Our legal experts and continued good counsel makes us extremely confident that we will win in our justified stance in all these cases. On the other hand, we will continue to lobby the Govt. to remove harsh regulations so that everyone: government, public and we manufacturers can co-exist in a peaceful and prosperous manner working towards mutual benefit and harmony. If this happens it will be a great achievement for CIPI and all of us.
- Immediate meeting with Drugs Controller General of India (DCGI)
There are many minor issues at the state and central level which are creating irritating bottlenecks in our paths and hindering the smooth functioning of our pharmaceutical industry. We will be taking up these issues with DGCI to resolve them at the earliest. These key issues are:
- Approval of additional items for domestic market, export market and Grant of state level COPP Certificates
In order to enable our member units to increase their markets and speed up time to market, DCGI and SLA’s have been requested by us to ensure speedy disposal of these urgent approvals and COPP Certificates
- Items permitted in other states
It has been noted that there is many a disparity in approving of drug formulations in many our states across India. Hence we are lobbying both at the central and state level to introduce a uniform policy of approval, pan India for drugs’ approval by all State Drugs Controllers.
As per provision of Drugs and Cosmetics Act, a routine factory inspection needs to be done once every year. However, it has been noticed that in case of any complaint against a manufacturer, the government officials insist on inspect the entire premises instead of just focusing on the department connected to the complaint. This arbitrary action hurts us manufacturers as it forces members to shut their entire unit more than once leading to many losses and hardships. We at CIPI are earnestly lobbying with authorities to remove this irritant and issue helpful directive for a complaints-specific inspection by their inspecting staff.
- Need for a Positive Attitude & Helpful Approach by all govt authorities:
It is a known fact that government statutes and functionaries are there to help industry and not burden it with inefficiency and unjustified fear-tactics. Hence we at CIPI are continuously trying to bridge this gap across all government bodies and officials. A positive attitude and helpful approach is urgently needed and advisable for everybody in today’s hyper competitive business environment. We are in constant touch with different SDCs and DCGI to remove process hindrances and improve industry-government connects.
- To further mutual assistance on industry problems and to make representations to the Government at all levels upon matters related to our industry.