About Pharmaceutical Industries in India

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The Indian pharmaceutical industry has shown tremendous progress in terms of infrastructure development, technology base creation and a wide range of production. Even while undergoing restructuring, it has established its presence and determination to flourish in the changing environment. The industry now produces bulk drugs belonging to all major therapeutic groups. Strong scientific and technical manpower and pioneering work done in process development have contributed to this.

Total production of bulk drugs and formulations during 1997-98 is estimated at Rs. 26280 million and Rs. 120680 million respectively. The growth rate has been around 15% for bulk drugs and 20% for formulations during ninetees. The performance on the export front is also noteworthy, clocking a growth rate of more than 20% in 1997-98. Nevertheless, the scope to increase the volume of exports is tremendous.

Technological Strengths

The following form the basis of the technological strengths of the Indian pharmaceutical industry:-
  • Self-reliance displayed by the production of 70% of bulk drugs and almost the entire requirement of formulations within the country
  • Low cost of production
  • Low R&D costs
  • Innovative Scientific manpower
  • Strength of National Laboratories  
  • Increasing balance of trade in pharma sector

Negative List of Items

Negative list of items under EXIM Policy 1997-2002

SNo EXIM   Code   Description Policy
1. 29362200.10 Vitamin B1 and its salts Restricted
2. 293623 00.10 Vitamin B2 and its salts Restricted
3. 293626 00.10 Vitamin B12 Restricted
4. 294110 01 Penicillin & its salts (eg. Procaine Penicillin, Penicillin G. Potassium) Restricted
5. 294110 02 Ampicilline & its salts Restricted
6. 294110 03 Amoxycilline & its salts Restricted
7. 294110 04 Cloxacilline & its salts Restricted
8. 294110 09.10 6-APA Restricted
9. 294120 00.10 Streptomycin Restricted
10. 294130 09.10 Tetracycline/Oxytetracycline & their salts Restricted
11. 294190 01.10 Rifampicin Restricted
12. 294190 01.2 3 Formyl Rifa S.V.(Rif int.) Restricted
13. 294190  01.30 Rifa S/Rifa S Sodium (Rifa int.) Restricted
14. 294190 01.40 1 Amino 4-methyl Piperazine (Rifa int.) Restricted
15. 300310 00 Containing Penicillins or derivatives thereof, with Penicillanic acid structure  or Streptomycins or their derivatives Restricted
16. 300410 01 Streptomycin &  its salts in capsules,injections etc. Restricted
17. 300410 02 Penicillin in capsules, injections etc. Restricted
18. 300410 03 Ampicilline in capsules, injections etc. Restricted
19. 300410 04 Amoxycillin in capsules, injections etc. Restricted
20. 300410 05 Cloxacillin in capsules, injections etc. Restricted
21. 300410 06 Ampicilline and Cloxacilline in capsules injections etc.   .
22. 300410 09 Other antibiotics with Penicillinic acid structure Streptomycin/ its derivatives in capsules, injections etc. Restricted
23 300420 02.10 Tetracycline and their salts .
24. 300420 05 Other formulations containing Tetra-cycline in capsules,.injections etc. Restricted
25. 300420 06 Chloramphenicol and Streptomycin formations thereof in capsules etc.   .
26. 300420 07 Rifampicin - formulations,in capsules  etc   .
27. 300450 05.10 Vitamin B1 and B2 and their salts .
28. 300450 05.20 Vitamin B12   .
Small Scale Unit

The present investment limit for units to qualify as a small scale unit is Rs. 3 crores. Some drugs are reserved for exclusive manufacture by the small scale units. These are given below:
  • Niacinamide
  • Paracetamol
  • Glycero Phosphates
  • Nicotinic Acid

Pharmaceutical Export Promotion Cell

The Export Promotion Cell in the Pharmaceutical Division acts as a nodal agency in the matters related to export of pharmaceuticals. In order to give adequate attention to day-to-day problems faced by the exporters, the Cell interacts with various Ministries/Departments and our Missions abroad. The Cell also collects statistical data on export and import of pharmaceuticals in the country and provides commercially useful information on developing and increasing drugs and pharmaceutical exports. The Cell has also been entrusted with organisation of seminars and workshops on standards, quality control requirements etc. of important countries so as to prepare domestic companies for exporting their products.

The Cell communicates with 131 Missions abroad to collect  information related to pharmaceutical industry in these countries such as, status of the pharmaceutical industry, details of documentation, guidelines for licensing of pharmaceutical companies as well as registration for medicines, details of pharmaceutical market with information on local production, demographic data, details of health care system, health indicators and prevalent disease pattern, details of imports of pharmaceuticals of these countries, details of joint venture units for pharmaceuticals operating in these countries etc. The Cell has started providing commercially useful information to the industry/exporters for boosting pharmaceutical exports.

For further details regarding Pharmaceutical Export Promotion Cell (PEPC), Please contact

Ms. Veenu Gupta
Deputy Secretary (PI)
Tel. : 3 3 8 7 7 6 1
Fax : 3 3 8 8 6 2 8
E-Mail : dspi.cpc@sb.nic.in

Shri V.A. Davis
Under Secretary (PI-III)
Tel. : 3 3 8 7 2 0 2
Fax : 3 3 8 8 6 2 8 : 3 3 8 7 2 0 2
Fax : 3 3 8 8 6 2 8

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